Course for STLS in NTEP

​

Resources

• Global Tuberculosis Report, 2020; Geneva: World Health Organization, 2020
• Training Modules (1-4) for Programme Managers and Medical Officers India: Central TB Division, MoHFW, Government of India,July 2020

• Globally, an estimated 11 million people fell ill with TB (incidence) in 2021.
• Historically, it has been the top infectious disease killer. In 2021, there were an estimated 1.4 million TB deaths and an additional 187 000 deaths among HIV-positive people.
• Three countries accounted for 42% of global cases in 2021: India (26%), the Russian Federation (8.5%) and Pakistan (7.9%).

Image Figure: Estimated TB incidence in 2021, for countries with at least 100 000 incident cases; Source: Global TB Report, 2022.

Resources​

• Global tuberculosis report 2022.

TB is one of the top burdensome infectious diseases in India. It is estimated that, around 1/4th (26%) of the world's TB cases are in India, translating to about 30 Lakhs new TB cases emerging each year (TB incidence). Against this estimated incidence the National TB Elimination program reported around 19 lakh new and relapse cases in the year 2021.

An estimated 5 Lakhs deaths occur due to TB each year in the country, translating to about 1 case of TB death every one-two minutes. Compared to this, there are only about 60 thousand deaths due to HIV and about 77 deaths due to Malaria each year.

TB diagnosis and treatment services although provided free of cost in the public sector, the cost of accessing these services and related loss of wages drive the affected people with poverty (catastrophic costs). TB also has a huge impact on the world's and the country's economy because of loss of workdays (100 million workdays per year).

Assessment

Resources:

• ^*WHO Global TB Report 2021
• ^{^}Status of National AIDS Response
• ^$PIB MOHFW

The interaction between HIV and TB in co-infected persons is bidirectional and synergistic; on the one hand, HIV infection predisposes the development of active TB, and, on the other, the course of HIV-related immunodeficiency is worsened by active TB infection.

Globally and in India, TB is the most common opportunistic infection seen in HIV patients and a leading cause of death in these patients. The lifetime risk of TB in immune-competent persons is 5-10%, whereas, in an HIV-infected person, the annual risk of TB is 5-15%. Thus, people living with HIV are 18 (15-21) times more likely to develop active TB disease than people without HIV.

TB and HIV Burden Trends in India

India is one of the WHO’s 30 high TB/HIV burden countries; of the 3 million TB incident cases, close to 54000 occurred in HIV-infected persons (See Table 1 for more details). TB and HIV are major public health challenges in India and are leading causes of mortality and morbidity among all other infectious diseases.

Resources

• India TB Report, 2022
• Global TB Report, World Health Organisation, 2022
• Shastri, S., Naik, B., Shet, A. et al. TB treatment outcomes among TB-HIV co-infections in Karnataka, India: how do these compare with non-HIV tuberculosis outcomes in the province?. BMC Public Health 13, 838 (2013)

TB is caused due to the infection by a bacterium called Mycobacterium tuberculosis.

It often affects the lungs, and in such cases it is called Pulmonary Tuberculosis. But, it can affect almost any part of the body (except the hair and the nails), in which it is known as Extra-Pulmonary Tuberculosis.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Tuberculosis is transmitted mainly through the air via droplet nuclei generated when a TB patient coughs or sneezes. 

It is estimated that every sputum smear-positive patient spreads the infection to 10 – 15 persons annually, if untreated..

Figure: Transmission of TB bacteria through air via droplet

Resources:

• Technical and Operational Guidelines for TB Control in India 2016
• WHO - Fact sheet details on Tuberculosis

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• TB Infection (or previously known as Latent TB infection) is a stage in between uninfected and having active TB. In this stage the person has no symptoms and can only be identified using laboratory tests.

• The vast majority of infected people may never develop TB disease. However, to achieve TB elimination, it is important to treat TB infection in people at risk of developing active TB disease.

• It is a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.

• There is no single acceptable/reliable test for direct identification of Mycobacterium tuberculosis infection in humans. Tuberculin Skin Test (TST) and Interferon-gamma release assay (IGRA) are commonly used tests for identifying TB infection.

Resources:

• Latent Tuberculosis Infection Guideline

• Guideline for Programmatic Management of Tuberculosis Preventive Treatment in India

After exposure to infective droplets containing M.TB, only a small proportion gets infected and further progresses to active TB disease.

• Majority of those that get infected persist in a stage of clinical latency known as TB infection (previously known as Latent TB infection). They do not have TB disease and do not show any symptoms of TB and no evidence of any TB related changes on chest X-ray.
• A small proportion of those with prior infection may progress to active TB disease due to various environmental/ agent/ host factors.

Figure: Flow chart for TB disease progression

Resources:

• Understanding delayed T-Cell Priming, Lung Recruitment, and AirwayLuminal T-Cell Responses in Host defence against Pulmonary Tuberculosis

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Resources:

• Technical and Operational Guidelines for TB Control in India 2016

The Epidemiologic Triad is a model used in the field of epidemiology to study diseases and how they are spread. It consists of a triangle with three vertices or corners. 

The three vertices for infectious diseases consist of:

1. Agent, or microbe that is the factor causing the disease.

2. Host, or organism harbouring the disease.

3. Environment, or those external factors that cause or allow disease transmission. 

In the Epidemiological Triad of TB (Figure), the agent is the TB causing bacteria Mycobacterium tuberculosis; the host refers to humans that are susceptible to TB. Susceptibility or the risk factors for acquiring TB can be:

• Close contact with a person having TB disease
• Nutritional status of the host
• Existing co-morbidities
• Low immunity.

Susceptibility of the host can also vary due to age, gender, genetic composition, race, ethnicity, etc. 

As TB is an airborne disease, environmental factors come into play for the transmission of TB. These include crowding, poor ventilation, bad sanitation, indoor air pollution, etc. 

The understanding between the interplay of agent, host and environment is essential to understanding the epidemiology of TB and taking measures to control it. The risk of TB due to environmental factors can be reduced by practising airborne infection prevention measures like good ventilation, hand hygiene and cough etiquette. 

Figure: Epidemiological Triad of TB

Resources

• Understanding the Epidemiologic Triangle through Infectious Disease, CDC. 

• Epidemiological Triad of TB.

   

Assessment

Determinants are any characteristics that affect the health of a patient.

TB can affect anyone but it is more prevalent in some communities which are vulnerable to TB disease due to various factors which are mentioned below:

Increased exposure of TB due to where they live or work

• prisoners
• slum dwellers
• miners
• hospital visitors
• healthcare workers

Limited access to Quality TB services

• Migrant workers
• Women in settings with gender disparity,
• Children
• Physically challenged
• Transgender population
• Tribal and population living in hard to reach areas
• Refugees or internally displaced people
• Illegal miners and undocumented migrants

Increased risk because of biological or behavioural factors that compromise immune functions in people who:

• People who live with HIV
• have diabetes or silicosis
• undergo immunosuppressive therapy
• are undernourished
• use tobacco
• suffer from alcohol use disorders.
• inject drugs 

As TB is an airborne infection, TB bacteria are released into the air when someone with infectious TB coughs or sneezes. The risk of infection can be reduced by taking simple precautions:

Figure: Measures for control and prevention of tuberculosis

TB Preventive Treatment(TPT) also has a very important role in prevention of TB. Presently, household contacts of sputum-positive TB patients are given TPT upon confirmation of TB infection and ruling our active Tuberculosis.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Chemotherapy for TB is the use of an anti-TB drugs to kill, or prevent the replication of, TB mycobacteria in the patient’s body. Effective anti-TB chemotherapy renders the patient non-contagious and cures the patient, thereby interrupting the chain of transmission. Mortality rates of TB range from 50-80% in untreated smear-positive individuals and drop to lower than 5% under chemotherapy.

Most of the bacteria are killed during the first 8 weeks of treatment; however, there are persistent organisms that require longer treatment. TB disease must be treated for at least 6 months and in some cases even longer. The use of multi-drug therapy reduces the incidence of drug-resistant cases and increases the overall effectiveness of treatment.

If treatment is interrupted, any surviving bacteria may cause the patient to later become ill and infectious again, potentially with drug-resistant disease.

How infectious are tuberculosis patients under chemotherapy?

Under effective chemotherapy, there is a substantial decline in infectiousness in two weeks time, and may not be a major source of risk to any contacts. This decline is indicated by the rapid fall in the number of viable organisms in the sputum, and reduced frequency of coughing.  

Types of Chemotherapy in TB

1. Preventive Chemotherapy: Regimen for healthy but TB infected persons with a high risk of developing TB, in order to prevent them from developing TB.
2. Standard Chemotherapy: Two-phased chemotherapy for an average of 6-8 months based on the combination of at least four major drugs (HRZE) given for 2 months during the initial intensive phase of treatment and followed by a combination of at least 2 drugs given for at least 4 months during the continuation phase of treatment.
3. Chemotherapy for Drug-resistant TB: Two-phased chemotherapy varying from 9 - 24 months in patients having demonstrated resistance to drugs used in standard chemotherapy. The regimen varies with the drug to which the resistance is present, however, each regimen contains a mix of second-line anti-TB drugs including injectables.   

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Infectiousness and Host Susceptibility, The Journal of Infectious Diseases, Vol. 216, suppl_6, 2017.
• Tuberculosis chemotherapy: Current Drug Delivery Approaches, Respiratory Research 7, Article no. 118, 2006.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

Incidence is an epidemiological measure of the occurrence of new cases of a disease in a population over a specified period of time. Tuberculosis (TB) incidence is the number of new cases of active TB disease during a certain time period (usually a year), and is better expressed as a rate, as shown in the figure below.

Figure: Deriving the Incidence of TB Disease for a Given Population

Tuberculosis incidence varies considerably in different populations and population segments.

In 2021, the Global TB incidence was 134 (125-143) per 100,000. The TB Incidence rate of India is  - 210 (178-244) per 100,000 in 2021 according to WHO Global TB Report 2022.

Resources

• India TB Report, 2022.
• Epidemiologic Basis of Tuberculosis Control, Hans L. Rieder, 1999.
• Morbidity Frequency Measures, Centers for Disease Control and Prevention.
• Global Tuberculosis Report 2022.

Prevalence is an epidemiological measure of the proportion of a population with a disease or a particular health condition at a specific point in time (point prevalence) or over a specified period of time (period prevalence).

Tuberculosis (TB) prevalence refers to the number of people with TB that are present in a particular population at a given time. Calculation of the TB prevalence rate is shown in the figure below.

Figure: Deriving the Prevalence of TB Disease for a Given Population

TB prevalence rate is derived by adding the number of persons that develop new TB disease (i.e., incident cases​) and those who already have the disease (i.e., existing cases), and dividing the sum by the total population from which the cases arose.

TB prevalence varies widely and is affected by a number of factors such as age, gender, population density, rural/urban settings, as well as socioeconomic factors.

Resources

• Epidemiologic Basis of Tuberculosis Control, Hans L. Rieder, 1999.

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TB notification rate is the number of TB cases notified over a specified time period for a specified population, usually per lakh. It indicates how many cases have been diagnosed and informed to the National TB Elimination Program.

It is mostly calculated annually, and the calculation formula is as follows: 

Figure: Deriving the Annualized TB Case Notification Rate

The National TB Elimination Program calculates TB notification rates based on TB cases notified using the digital surveillance system called Nikshay. Each state/district is provided with an annual target for TB case notification, the progress of which is measured periodically to understand efforts taken for the detection of TB cases.

Example

If the number of TB patients diagnosed in District X one year is 1000, and the mid-year population of District X is 10,00,000, then the annualized TB case notification rate is calculated as follows: 

100 cases/100 000/year

Resources

• NTEP training module for medical officers 5-9
• TB Notification Rate, TB Indicators WHO 2014

The World Health Organisation End TB Strategy, adopted by the World Health Assembly in 2014, aims to end the global TB epidemic. The strategy draws on the opportunities presented by the Sustainable Development Goals (SDGs), especially those goals aimed at achieving universal health coverage and social protection from disease.

The table given below provides information on the vision, goal, milestones and targets for the End TB Strategy.

The National Strategic Plan (2017-2025) proposes bold strategies with commensurate resources to rapidly decline TB in the country by 2030 in line with the global End TB targets to attain the vision of a TB-free India.

Resources

• National Strategic Plan for Tuberculosis Elimination 2017–2025.
• The End TB Strategy, World Health Organisation, 2015.

Figure: Summary of the Sustainable Development Goals

• Goal 3 is related to Good Health and Well-being. It mentions that 'Each nation needs to ensure healthy lives and promote the well-being of all ages'.
• The United Nations Sustainable Development Goals (SDGs) include ending the TB epidemic by 2030 under Goal 3.
• Goal 3.3: By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases.

India is a signatory of the United Nations Sustainable Development Goals and has targeted TB elimination by 2025, five years ahead of the SDG timeline.

Resources

• United Nations, Department of Economic and Social Affairs. 
• SDG Booklet, UNDP.

The National Tuberculosis Control Program (NTP) of India was launched in 1962. It relied on BCG, X-ray based diagnosis and Streptomycin and INH based treatment centralized at district level.  

Based on a review of the NTP, and WHO recommendations of the DOTS Strategy, Government of India then revised the NTP and launched new program with the title Revised National Tuberculosis Control Program (RNTCP) in 1997. It used Sputum microscopy at DMC(Designated Microscopy Centres) for diagnosis, and multi-drug Short Course Anti-TB Therapy,  decentralized to the TU (TB Unit) level. 

In recognition of the rising drug resistance problem the DOTS Plus/ PMDT (Programmatic Management of Drug Resistant TB) was launched in 2006 and scaled up to the entire country by 2012. 

Further to strengthen the monitoring and supervision system - a case based notification system - Nikshay was introduced in 2012. The same year Tuberculosis was added as a notifiable disease at the point of diagnosis by all health care providers.

Other key milestones from 2012 to 2020 were the availability of the Standards of TB Care in India (STCI) in 2014, introduction of the Daily weight band wise Fixed Dose combination (FDC) in 2016 and new drugs like Bedaquilline  and Delaminid were started in 2017 and 2018 respectively. 

To emphasise the commitment of the Government of India and to accelerate the efforts towards TB elimination, RNTCP was renamed as "National Tuberculosis Elimination Programme (NTEP)" in 2020.

Figure: Key milestones under NTEP

Resources:

• TBC India Website
• National Stratergic Plan for Tuberculosis Elimination 2017 - 2025

The Government of India has committed to achieving the Sustainable Development Goals(SDG) targets related to ending TB by 2025 (5 years ahead of the global target).  This would mean that in 2025, the 2030 target of achieving 80% reduction in incidence, 90% reduction in deaths due to TB compared to that of 2015, is to be achieved.

Table: India's commitment to End TB by 2025.

Resources:

• National Strategic Plan (NSP) - 2017 - 2025
• Global TB report 2021
• END TB Strategy

The National Strategic Plan (NSP) for TB elimination 2017–25 is a bold strategic framework to drive the  acceleration of progress toward TB Elimination, and achieving the Sustainable Development Goal (SDG) and End TB targets for India. It expects to guide the activities of all stakeholders including the national and state governments, development partners, civil society organizations, international agencies, research institutions, private sector, and many others whose work is relevant to TB elimination in India. It is adopts strategies under four groups DETECT, TREAT, PREVENT, BUILD.

VISION: TB-Free India with zero deaths, disease and poverty due to tuberculosis
GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB in India by 2025.

The results framework of the NSP outlines the various targets (impact and outcomes) to be achieved.

Resources

• Revised National Tuberculosis Control Program National Strategic Plan For Tuberculosis Elimination 2017–2025, Central TB Division, MoHFW, 2017

Assessment Questions

NSP 2012 - 2017 had the aim of achieving universal access to quality diagnosis and treatment. The NSP 2017-2025 which builds on the success and learnings of the last NSP, and articulates the bold and innovative steps required to move towards TB elimination. In 2020, RNTCP was renamed to "National Tuberculosis Elimination Programme" with the following objectives:

Figure: Objectives of NTEP

Resources:

• TBC India Website

National Tuberculosis Elimination Programme (NTEP) is a centrally sponsored programme being implemented under the aegis of National Health Mission.

National Level: Managed by Central TB Division (CTD), the technical arm of the Ministry of Health and Family Welfare (MOHFW)

State Level: State TB Cell coordinates the overall TB elimination programme in state under the guidance of State Health Society. The training ,supervision, monitoring and evaluation NTEP at state level are looked after by STDC (State TB Training and Demonstration Centre).

District TB Centre (DTC) is the nodal point for all TB elimination activities in the district under the guidance of the District Health Society.

Tuberculosis Unit (TU) Level: NTEP activities at block/sub-district level are implemented through TU which comprises Designated Medical Officer (MO) supported by two full-time NTEP staff - STS (Senior Treatment Supervisor) & STLS (Senior TB Lab Supervisor).

PHI (Peripheral Health Institute): PHI is a health facility manned by a Medical Officer (MO). Some of the PHIs are also the Tuberculosis Diagnostic Centres, which are the most peripheral level laboratories in the NTEP structure. All the Private Health Facilities like Private Practitioners / Private Hospitals / Clinics / Nursing Homes are also PHI.

Figure: Organisational structure of NTEP

Resources:

• TB India Report 2021
• Technical and Operational Guidelines for TB Control in India 2016

The State TB Cell or STC is the state-level implementing structure of the National TB Elimination Program (NTEP). It is the leading institution for management of NTEP activities at the state level. 

The STC is a State Government entity that acts as the bridge between the Central and State Governments for implementing the NTEP. It works under the guidance of the Central TB Division (CTD), and it oversees the program implementation at the districts.

1. The State TB Cell is supported by the State TB Training and Demonstration Centre (STDC) for its technical functionalities. STDC mainly supports training, supervision and monitoring.
2. The nodal laboratory for the State is the Intermediate Reference Laboratory (IRL). This supports quality assurance of the smear microscopy network and laboratory services in the state.
3. The STC has a fully operational State Drug Store (SDS) which is responsible for the effective management and uninterrupted supply of good-quality of medicines and other logistics.

Human Resources at the State TB Cell are:

1. State Tuberculosis Officer (STO). A dedicated official from the state health system, at the rank of a Joint Director is designated as the STO and heads the implementation of the NTEP at state level.
2. Medical Officer STC (MO-STC): A medical officer from the state health system assists the STO in overseeing various activities.
3. State DRTB Coordinator​: Assist the STO in DRTB activities monitoring across the districts
4. TB - HIV Coordinator: Assist the STO in overseeing TB comorbidities across the district.
5. State PPM Coordinator: Looks at the private sector engagement
6. State IEC Officer/ACSM Officer: Oversees the implementation of advocacy, communication and social mobilisation activities across different districts.
7. STC - Epidemiologist: Assist the STO and STDC Directors by analyzing state-level data and preparing review materials
8. Other support staff at the STC include
   1. Accounts Officer
   2. Technical Officer-PSM
   3. Secretarial Assistant
   4. Data entry operators/Nikshay operator

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Training Modules (5-9) for Programme Managers and Medical Officers, 2020.

Assessment

The State Tuberculosis (TB) Cell (STC) is supported by the State TB Training and Demonstration Centre (STDC) in many states through its three units – Training Unit, Supervision and Monitoring Unit and an Intermediate Reference Laboratory (IRL). This relationship is shown in the figure below.

1. Training Unit: It is involved in estimating the training load, organizing state level training (Induction and Refresher) and evaluating the performance of those who undergo training.
2. Supervision and Monitoring Unit: It consists of a team which is dedicated to the supervision of TB elimination activities through supervisory visits, periodic desk review of Nikshay and Nikshay Aushadhi data, and plans state internal evaluations apart from assisting in other supervision and monitoring activities of National Reference Laboratories, Central TB Division and other national/international monitoring missions.
3. Intermediate Reference Laboratory: This supports an effective quality assurance system of the sputum smear microscopy network and laboratory services for the programmatic management of drug-resistant TB (molecular drug resistance and culture and drug susceptibility testing) in the state.

The STDC is also involved in operational research.

Human Resources in the STDC

• The STDC functions under the leadership of STDC Director. 

Training and Supervision & Monitoring Units:

• 1 Epidemiologist
• 1/more Medical Officer
• 1 Nikshay Operator
• 1 Secretarial Assistant

Intermediate Reference Laboratory (IRL):

• 1 Microbiologist
• 1 Microbiologist- External Quality Assistance (EQA)
• 1 Senior Laboratory Technician- EQA

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Training Modules (5-9) for Programme Managers and Medical Officers, 2020.

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The key level for the management of public health services is the district​ level. The District Tuberculosis Centre (DTC) is the nodal point for tuberculosis (TB) control activities in the district​.

Functions of the DTC

The primary role of the DTC is a managerial one. The DTC is the central program management unit of the district responsible for all activities related to National TB Elimination Programme (NTEP) implementation such as:

• Advocacy
• Active case finding
• Diagnosis, treatment (both for drug-susceptible and drug-resistant TB cases) and follow up
• Managing comorbidities
• Service delivery
• Maintaining diagnostic and treatment infrastructure
• Setting up Drug-resistant TB (DR-TB) centres
• Ensuring community engagement and TB forums
• Multi-sectorial involvement for drug management, and supervision and monitoring
• Financial management
• Drugs, logistics and supply chain management.

Components of the DTC

1. District Drug Store (DDS)
2. Nucleic Acid Amplification Test machine (Cartridge Based NAAT or TrueNAT)
3. Designated Microscopic Center (DMC)
4. Treatment Support Center
5. Drug Resistant TB (DR-TB) Center
6. X-Ray Unit

With expansion of TB services and ongoing collaboration with various national programs, the structure of DTC is highly integrated as part of general health system and some components may cater to non-TB patients as well e.g., the DMC may be a part of general laboratory, and X-ray unit can be functional for all departments and not just chest/TB section.

Human Resources Deployed at the DTC

The Chief District Health Officer (CDHO) / Chief District Medical Officer (CDMO) / Civil Surgeon or an equivalent functionary in the district is responsible for all medical and public health activities including control of TB.

A full-time District TB Officer (DTO), trained at the national level and based at the DTC, is responsible for planning, training, supervising and monitoring the programme in the district. The DTO is assisted by other technical and secretarial staff:

1. Medical Officer- District TB Center
2. District DR-TB-HIV Coordinator
3. District Public Private Mix Coordinator
4. District Program Coordinator
5. District Drug Store Pharmacist
6. District Data Entry Operator-Nikshay
7. District Accountant
8. Senior TB laboratory Supervisor
9. Senior Treatment Supervisor
10. Laboratory Technicians for DMC and NAAT site
11. Counsellor for District DR-TB center
12. TB Health Visitors

While the National TB Elimination Program (NTEP) approves the above positions through National Health Mission NTEP Project Implementation Plan, the district always has the flexibility for additional resource deployment based on the need and existing epidemic. The DTO and his/her team are supported by various other program officers/staff and non-governmental organizations working in the field for Tuberculosis and Health.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.

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Tuberculosis (TB) unit (TU) is the sub-district level supervisory unit of National TB Elimination Program with the following organogram:

Figure: Organogram of a TB Unit

(PHI: Peripheral Health Institution)

TUs are based mainly on National Health Mission (NHM) health blocks with the aim of aligning with the NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring.

The TUs have been created based on a population of 1 per 2,00,000 (range 1.5 – 2.5 lakh) for rural and urban populations and 1 per 1,00,000 (0.75 – 1.25 lakh) population in hilly/tribal/difficult areas.

The TU consists of a designated Medical Officer-Tuberculosis Control (MO-TC), as well as one full-time supervisory staff - Senior Treatment Supervisor (STS). However, one Senior TB Laboratory Supervisor (STLS) will be there in every 5 lakh population (one per 2.5 lakh population for tribal/hilly/difficult areas), mostly covering 2-3 TUs.

TB Unit manages the provision of TB services (Diagnosis, Treatment, Prevention, etc.) and programme management in the assigned geographical area. 

Resources

• RNTCP Technical and Operational Guidelines for TB Control in India 2016.
• Training Modules (1-4) for Programme Managers & Medical Officers, 2020.

Under the National Tuberculosis Elimination Programme (NTEP), a Peripheral Health Institute (PHI) is a health facility that is manned by at least a Medical Officer (MO), where diagnosis and management of Tuberculosis (TB) are done.

At this level, there are dispensaries, Primary Health Centres (PHCs), Community Health Centres (CHCs), referral hospitals, major hospitals, speciality clinics or hospitals (including other health facilities), TB hospitals, Anti-retroviral Treatment (ART) centres and medical colleges within the respective district.

All health facilities in the private and Non-government Organisation (NGO) sectors participating in NTEP are also considered PHIs. Some of these PHIs also function as Designated Microscopy Centres (DMCs).

Role of PHIs in Program Management for TB Elimination

• PHIs undertake tuberculosis case-finding and treatment activities as a part of the general health services.
• In situations where more than one MO is posted in any of the PHC, one of them may be identified and entrusted with the responsibilities of the NTEP.
• Additionally, NTEP provides 1 TB Health Visitor (TBHV) per one lakh urban population to support the urban TB control activities in urban settings/ medical colleges.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.

Drug-resistant Tuberculosis Centres (DR-TBCs) are specialized centres for the clinical management of Drug-resistant TB (DR-TB). ​

Each DR-TBC needs to have established a DR-TB committee to carry out the clinical management of DR-TB patients.​

DR-TBCs can be established in the public sector where appropriate facilities are available. ​

• The DR-TBC can also be established in the private sector on mutually agreeable terms and conditions based on the Guidance Document on Partnerships, 2019.

District level:  There are District Drug-resistant TB Centres (DDR-TBCs) to manage DR-TB cases. ​These centres will function under the guidance of Nodal Drug-resistant TB Centres (NDR-TBCs). Almost every district has a mandate to establish a DDR-TBC in India. There are around 620 DDR-TBCs established in the country.​

State/ Regional level: At the state/ regional/ division level, there are NDR-TBCs to manage seriously ill DR-TB cases. ​There are 173 NDR-TBCs established in India.​

Decentralized DR-TB services through an expanded network of DR-TB centres has helped the National TB Elimination Program in improving access to DR-TB services and has also resulted in improved DR-TB treatment linkage and better management of DR-TB patients.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

Image

DRUG STORE

Central TB Division, MoHFW, has

Under NTEP, there is a large network of drug stores across the country to ensure a regular and uninterrupted supply of drugs and consumables. The Drugs and consumables are procured at the Central level and supplied at Central warehouses (GMSDs & CMSS); further drugs and consumables are supplied to the State Drug Stores and further dissemination to district and sub-district levels following the stocking norms to ensure uninterrupted supply of drugs and consumables to the patient.

To provide overall policy guidance and coordination, the Procurement and Supply Chain Management (PSM) Unit has been established at Central TB Division (CTD), MoHFW, for procurement and Supply Chain Management of all types of anti-TB drugs, diagnostics and consumables.

The Standards for TB Care in India (STCI), which is a locally customized version of the International Standards of Tuberculosis Care, mentions 26 standards that every citizen of India should receive irrespective of the sector of treatment. 

STCI were developed based on a series of discussions involving various stakeholders including clinicians, public health specialists, community workers and patient advocates. 

STCI represent what is expected for quality TB care from the Indian healthcare system including both public and private systems. 

It was first published in 2014 and outlines standards across the four themes of TB diagnosis, TB treatment, public health action and social inclusion.

Following are the list of the 26 Standards:

Table 1: Categorisation of the Standards for TB Care in India, Source: Standards for TB Care in India, World Health Organisation, pp. 13-23

Resources

• Standards for TB Care in India, World Health Organisation, 2014

Assessment

Those who are suspected of having TB disease are first screened for symptoms like cough and fever for more than 2 weeks, blood stained sputum and weight-loss. If found positive on screening, then TB patients are referred for testing to the nearest health facility. If diagnosed with TB, then they are subsequently initiated on treatment. The TB patients initiated on treatment are regularly monitored with the help of field staff or digital interventions like 99DOTS and MERM (Medication Event Reminder Monitor) technology. NTEP staff also ensures that the TB patients are regularly followed up on monthly basis till their treatment completion.

Figure: Patient Flow

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The Senior Tuberculosis Laboratory Supervisor (STLS) interacts with the TB patient care ecosystem from the time a presumptive TB case is identified, examined, diagnosed, notified, and put on anti-tuberculosis treatment till the completion of treatment.

The key interactions include:

• Coordination with the Medical Officer (MO) of various dispensaries and other health establishments to ensure referral of the presumptive TB cases to the Designated Microscopy Centers (DMCs) and Nucleic acid amplification test (NAAT) laboratories for diagnosis of TB and DR-TB.
• Coordination with laboratory technicians of the DMCs and NAAT laboratories for results of TB diagnosis, follow-up, and sending samples for further testing to the designated Intermediate Reference laboratories (IRLs).
  • STLS is also responsible for providing monthly supply of staining regents, consumables, NAAT cartridges and chips to the LTs of the DMC and NAAT Laboratories.  
  • STLS is the key person for ensuring quality assured TB diagnosis in the district. This is done by performing activities like On-site evaluation (OSE) visits, Random Blinded Rechecking (RBRC) of smears and providing quality assured staining reagents to the DMCs. 
• Coordination with Senior Treatment Supervisor (STS) to ensure that all TB patient diagnosed are initiated on treatment.
• Coordination with STS and PMDT Coordinator in updation of relevant NTEP records, line-list of presumptive DR-TB patients and preparation of Quarterly Reports
• The STLS interacts with the health care staff to facilitate change management with respect to use of Information and Communications Technology (ICT) and Ni-kshay tools for concerned data entry, validation & its use for public health action.
  • STLS ensures that the laboratory results related to diagnosis and subsequent follow-ups are updated by the LTs in a timely manner.
• STLS constantly Interacts with the District Drug Store (DDS), pharmacist and District TB Centre (DTC) to ensure adequate supply of CBNAAT cartridges and Truenat Chips to the NAAT laboratories and also keeps a track of transaction related to receipt and dispatch of these Cartridges and Chips.
  • This process is undertaken by the use of Ni-kshay Aushadhi. SLTS uses Ni-kshay Aushadhi for request generation, inventory management, and issue of cartridges and Chips to NAAT laboratories.
• The STLS supports assigning treatment support centers and treatment supporters for the patient. The treatment supporters may be community volunteers accessible, willing, and acceptable to the patient and who can be accountable to the health system. These include Anganwadi workers, dais, teachers, panchayat leaders, religious leaders, and others.
• The STLS coordinates with District TB Officer (DTO) and DTC to conduct monthly and quarterly review meetings.
• The STLS is crucial in undertaking active case finding activities and  organizing community-based Information, Education and Communication (IEC) activities like patient-provider group interaction meetings and community meetings in coordination with the support of field staff, which includes the ASHA workers, Community Health Officer (CHO), Multipurpose Health Worker (MPHW), and Auxiliary Nursing Midwife (ANM).
• The STLS coordinates with the private health care settings including the standalone laboratories in the districts to ensure that the patients diagnosed in these facilities are notified to the programme and appropriate public health action is taken when required.

Resources

• Training Modules (5-9) for Programme Managers and Medical Officers, NTEP, CTD, MoHFW, GoI, 2020. 

Assessment

The National Health Mission (NHM) was launched by the Government of India in 2013, subsuming the National Rural Health Mission (NRHM) and National Urban Health Mission (NUHM). Figure 1 shows the history of the NHM.

The vision of NHM is “Attainment of Universal Access to Equitable, Affordable and Quality health care services, accountable and responsive to people's needs, with effective intersectoral convergent action to address the wider social determinants of health.”

Image

Figure 1: History and Make-up of the NHM; Source: Annual Report 2015-16, Ministry of Health and Family Welfare (MoHFW)

NHM further aims to support the existing national programmes of health and family welfare (Figure 2) including reproductive and child health, malaria, blindness control, iodine deficiency, filariasis, kala-azar, tuberculosis (TB), leprosy, and integrated disease surveillance.

Image

NHM and the National Tuberculosis Elimination Program (NTEP)

Integrating the NTEP with the health system increases the effectiveness and efficiency of TB care and control. India's TB control programme has been mainstreamed efficiently with the NHM.

The overall responsibility for the financial management of the NTEP is with the MoHFW, Director General of Health Services (DGHS) through the NHM.

At the state level, the State Health Society or its equivalent under the NHM of the state manages the financing of the TB Control Programme.

At the sub-district level, the TB Unit (TU) is the nodal point for TB control activities. TUs are based mainly in NHM health blocks with the aim of aligning with the NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring.

Resources

• Annual Report 2015-16, Chapter 2: NHM, Ministry of Health and Family Welfare (MoHFW).
• Information on the NHM, NHM India, 2020.
• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

Medical colleges in the country are integrated with the National TB Elimination Programme (NTEP) to widen access and improve the quality of TB services. Medical colleges provide specialized services for seriously ill TB patients.

The integration of medical colleges in the program is in a structured task force mechanism at different levels:

• National
• Zonal
• State  

One national and six zonal task forces have been formed under the programme along with task forces for all states. A core committee is also formed in each medical college. These task forces are created with defined roles and responsibilities for the effective involvement of medical colleges in the programme.

Core Committee

Every medical college will have core committees representing various hospital departments and NTEP nodal officers. These committees meet quarterly and review the implementation of the program in the medical college.

Functions of the core committee:

• They organise sensitisation workshops and training for faculty members, postgraduates, undergraduates, interns, paramedical staff, etc. ​
• Ensure that teachings on TB/ NTEP form part of the curriculum for all medical colleges.
• Coordinate between various departments so that patients get the services under one roof.
• Coordinate with the district TB programme. ​

​Role of Medical College in NTEP

1. Medical colleges coordinate with the district TB programme for participation in quality assurance, supervision, monitoring, review and evaluation.
2. Operational research is one of the important activities of medical colleges. 
3. Every medical college should have TB detection facility and treatment support centres. These centres are equipped with trained additional human resources such as medical officers, laboratory technicians and TB health visitors.
4. The National Medical Commission insists that all Medical Colleges should also have facilities to manage DR-TB patients.
5. Medical colleges undertake advocacy for the programme.
6. Medical colleges also functions as peripheral health institutes (PHI), maintain TB notification registers and submit monthly PHI reports​: They have Nikshay user access and need to enter TB-related data on a real-time basis. 

Resources

RNTCP Technical and Operational Guidelines for Tuberculosis Control in India, 2016.

Assessment

• The public health system in India through the National Health Mission (NHM) visualises the attainment of Universal Health Coverage (UHC) for all its citizens, which provides access to equitable, affordable and quality health care services, which is also accountable and responsive to the needs of the people.

• Under the umbrella of NHM, the National TB Elimination Programme (NTEP) ensures the provision of free TB services (diagnostics and drugs) and management of TB as per the Standards for TB Care in India (STCI).

• Furthermore, the NHM, under the Ayushman Bharat initiative has taken measures to strengthen the primary care facilities including Primary Health Centres (PHCs) and Sub Health Centres (SHCs) in the Ayushman Bharat Health & Wellness Centres (AB-HWCs).

Need for integration of NTEP with the Health System at Different Levels

1. Closer to community TB Services: The integration of TB services with the health system provides an opportunity for the TB programme to leverage the resources under the Ayushman Bharat initiative to take TB interventions closer to the community which were otherwise provided at the primary care level.
2. Improved population coverage: Active empanelment and HWC database will help to monitor and identify the left-out population and contribute significantly to the NTEPs case finding activity coverage.
3. Improved population health outcomes: Improved availability, access and utilisation of advanced TB treatment services under the ambit of UHC is essential in reducing morbidity and mortality from TB which may in turn also contribute to overall equitable health outcomes.
4. Reduced out-of-pocket expenditure: The integration will improve the access to TB services, assure within-reach TB medicines and diagnostic services, provide linkages for care coordination with Medical Officers/ specialists across various levels of care, etc., all of which will reduce the catastrophic expenditures faced by the patients and their families.
5. Decreased crowding at the secondary and tertiary health facilities: A strong network of peripheral level TB care services would facilitate in reduction of the overcrowding and the case burden at the secondary and tertiary facilities, which could be utilised for cases with follow-up referral to higher level facilities.
6. Increased responsiveness and addressal of social determinants of TB: Provision of TB treatment at the nearest point of care for the communities and engaging the most peripheral workers from the health system like the Accredited Social Health Activists (ASHA) in the TB programme may lead to comfort in accessing the care by the patients and also enable addressing psycho-social determinants of TB.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, CTD, MoHFW, India, 2020.
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD.

Assessment

National Tuberculosis Elimination Programme (NTEP) strives for all presumptive TB patients to be microbiologically confirmed. Under NTEP, the acceptable methods for microbiological diagnosis of TB are: 

Rapid diagnostic molecular test: Rapid molecular tests that use techniques like NAAT are very specific. They amplify the genomic material in the patient sample and hence enhances detection

• Nucleic Acid Amplification Test (NAAT) e.g., GeneXpert, TrueNat

  

  Figure: Genxpert Machine for CBNAAT

  

  Figure:  Truenat Machine

• Line Probe Assay

Cartridge Based Nucleic Acid Amplification Test (CBNAAT) is a rapid molecular diagnostic test. It is used for diagnosis of Tuberculosis (TB) and Rif-resistant Tuberculosis (RR-TB) in NTEP. Results are obtained from unprocessed sputum samples in about 2hours which helps in early detection and treatment of TB patients. 

India has vast number of CBNAAT laboratories which are utilized for TB/RR-TB detection and Universal Drug Susceptibility Testing (UDST) under the National TB Elimination Program (NTEP).  

Figure: CBNAAT Cartridge and Machine in Use (Image courtesy: USAID supported Challenge TB Project)

The CB-NAAT system detects DNA sequences specific for Mycobacterium tuberculosis complex and rifampicin resistance by Polymerase Chain Reaction (PCR). It concentrates Mycobacterium tuberculosis bacilli from sputum samples, isolates genomic material from the captured bacteria by sonication and subsequently amplifies the genomic DNA by PCR. The process identifies clinically relevant rifampicin resistance-inducing mutations in the RNA polymerase beta (rpoB) gene in the Mycobacterium tuberculosis genome in a real-time format using fluorescent probes called molecular beacons.

Video: Cartridge-Based Nucleic Acid Amplification Test [CBNAAT] - GeneXpert Technology 

Resources

• Training Module (1-4) for Program Managers and Medical Officers, NTEP, MoHFW, 2020.
• India TB Report 2021, National TB Elimination Program (NTEP), MoHFW, 2021.

Assessment Questions

Line Probe Assay (LPA) is a rapid molecular test available at centralised laboratories.

The assay is based on Polymerase Chain Reaction (PCR) that can simultaneously detect Mycobacterium tuberculosis complex as well as drug sensitivity to anti-TB drugs.

Figure 1: The GenoType MTBDRplus Molecular LPA Procedure; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Advantages of LPA

• Rapid molecular test. (Turnaround time: 3-5 days)
• Highly sensitive and specific.
• Performed directly from sputum smear-positive specimens and on isolates of M. tuberculosis complex grown from smear-negative and smear-positive specimens.
• Detects multiple gene mutations in anti-TB drugs.
  • First-line LPA detects mutations to rifampicin and isoniazid
  • Second-line LPA detects mutations to fluoroquinolones and aminoglycosides.
• Suitable for low and high-throughput labs.

Disadvantages of LPA

• Cannot be used as a point-of-care test.
• Requires appropriate laboratory infrastructure, equipment and biosafety precautions.
• Different rooms (DNA extraction, pre-amplification, amplification, post-amplification/ hybridization) are required to perform different steps (Figure 2).
• Requires trained manpower to perform tests and interpret test results.
• Stringent internal quality control is required to prevent contamination.

Figure 2: Amplification (A) and Post-amplification Laboratory (B) for LPA; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Resources

• Guidelines for PMDT in India, 2021.
• Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Assessment

Culturing TB Bacilli is well known and historic method for detection/ confirmation of Tuberculosis. It is a highly sensitive and specific phenotypic test; it can detect even a few viable bacilli in the sample (Upto 10 Colony Forming Units- CFUs). TB bacilli multiply in the culture and form colonies of TB bacilli which can are easily be identified.

Based on the growth media used Culture is divided in to two types, Solid and Liquid Culture methods. Types Culture:

• Solid Culture on Lowenstein Jensen media : Historic gold standard culture test. Results take usually upto 2 months (60 days).
• Modern Liquid culture systems: (e.g. BACTEC MGIT 960, BacT Alert or Versatrek etc.) Results take usually up to 42 days. 

Uses

1. Solid culture is the gold standard diagnostic test for TB. But it is not used for the purpose of TB diagnosis due to the long turn around time of 2 months. It is largely used for research purposes where it is used as the baseline test on which the sensitivity and specificity of other tests are calculated.
2. Liquid Culture is being used for follow-up monitoring of patients on drug resistant TB treatment to detect treatment failure. Liquid culture is also used for long term follow up patients who have successfully completed treatment to detect recurrence.
3. Liquid culture is used as a previous step to grow bacilli and obtain isolates prior to Drug Susceptibility Testing.
4. Liquid cultures are also used in TB prevalence surveys for its high sensitivity and specificity

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India 2021

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Culture Drug Susceptibility Testing (CDST) is a growth-based phenotypic method used to check the susceptibility of Mycobacterium tuberculosis strains to various first and second line anti-TB drugs. Mycobacterial resistance to a particular drug is identified if there is growth observed in culture in presence of that drug.

In NTEP CDST is the standard method to detect resistance in samples of patients who have tested positive on followup. While CDST is possible on both Solid and Liquid culture, currently, the NTEP utilizes only liquid culture as a method for DST, due to faster Turn around times.

CDST testing services are available under NTEP in designated, specialized laboratories called CDST Labs both in public and private sector. Currently there are 80 such laboratories (60 certified for First Line and 49 for Second line drugs). Such designated laboratories are subject to regular external quality assessment, often by the National Reference Laboratory at that region.

Quality assured DST to R, H, Z, Mfx, Lfx, Lzd, Am, Km and Cm are available across the country. 

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.
• Training Manual for Mycobacterium tuberculosis Culture & Drug Susceptibility Testing, NTEP, 2009.
• RNTCP Laboratory Network Overview, CTD, 2009.

NTEP laboratory network is comprising of National Reference Laboratories (NRLs), state level Intermediate reference laboratories (IRLs), Culture & Drug Susceptibility Testing (C & DST) laboratories and peripheral level laboratories. Peripheral level laboratories consist of  designated microscopy centres (DMCs) and NAAT labs.

NTEP has a quality assured laboratory network for bacteriological examination of sputum in a 3-tiered system.

Figure: Laboratory network of NTEP

Resources:

• TB India Report 2021

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• National Reference Laboratories (NRLs) conducts annual on-site evaluation/supervisory visits to laboratories for assessing the quality of microscopy, culture and drug susceptibility test (C&DST), and for improvement of the overall laboratory quality. 
• NRLs also assist Central TB Division (CTD), in developing laboratory guidelines, standard operating procedures (SOPs), and conduct training to state-level Intermediate reference laboratories (IRLs) and other technical issues.
• NRLs conduct C&DST training to the IRLs, and develop SOPs for the technical procedures, equipment maintenance, infection control and recording and reporting. 
• NRLs are also responsible for offering second-line drug susceptibility tests (DST) for multi-drug resistant TB (MDR-TB) treatment failures. 
• NRLs are responsible for the accreditation of the mycobacteriology laboratory for culture and drug sensitivity testing under the National Tuberculosis Elimination Program (NTEP).
• In addition, NRLs are also responsible for the conduct of research for the programme and evaluation of newer tools for the diagnosis of TB.
• The National Institute for Research in Tuberculosis (NIRT) Chennai, the Supranational Reference Laboratory (SRL) of the region is responsible for the external quality assurance of the other 5 NRLs. NIRT is in turn quality-assured through the SRL coordinating laboratory at Antwerp, Belgium. 

Assessment Questions

The Intermediate Reference Laboratories (IRLs) function as a culture and drug susceptibility testing (C&DST) facility for the state level.

In addition to performing CDST, IRL is also responsible for:

• Undertaking training on laboratory technologies for district and field level staffs
• Conducting on-site evaluation visits to districts for sputum microscopy at least once a year
• Undertaking panel testing of Senior TB Laboratory Supervisors (STLS) at each district linked to it
• Ensuring the proficiency of staff performing National Tuberculosis Elimination Programme (NTEP) smear microscopy activities by providing training to laboratory technicians and STLS

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• NTEP Laboratory Network.

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Under the National Tuberculosis Elimination Programme (NTEP), many labs are established at the regional level within states for providing Culture and Drug Susceptibility Testing (C&DST) facilities for presumptive TB/DRTB and for TB/DRTB patients. C&DST laboratories are mostly located in intermediate reference laboratories (IRLs) or medical colleges. There are 42 C&DST laboratories established under the programme in different geographies. Dedicated human resources are provided for the laboratories under the programme. Districts are linked with laboratories for providing facilities for Culture and DST using: Phenotypic Methods (Solid – Lowenstein Jensen (LJ), and Liquid Culture – Mycobacteria Growth Indicator Tube (MGIT)) Genotypic technology (Line Probe Assay (LPA) and Cartridge Based Nucleic Acid Amplification Test (CBNAAT))

Figure: Culture and Drug Susceptibility Testing (C&DST) facility, Source: The Foundation For Innovative New Diagnostics (FIND)

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021
• Training Modules (1-4) for Programme Managers and Medical Officers; New Delhi, India: Central TB Division, July 2020

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The National Tuberculosis (TB) Elimination Program (NTEP) has a network of Nucleic Acid Amplification Tests (NAAT) laboratories coupled with Designated Microscopy Centers (DMCs) to form the backbone of the diagnostic component of TB services.

Nucleic Acid Amplification Tests (NAAT) laboratories includes Cartridge-based NAAT (CBNAAT) and TrueNat tests. These tests detect tuberculosis as well as rifampicin resistance and are more sensitive than smear microscopy.

Functions of Nucleic Acid Amplification Test (NAAT) Laboratories:

1. Acting as a hub for collection of samples from public and private health facilities (spokes)
2. Universal Drug Susceptibility Testing (UDST) to rule out rifampicin resistance among confirmed TB patients
3. Timely provision of NAAT test result to the TB patient, medical officer of the concerned health facility and NTEP staff for related actions
4. Acting as a sample dispatch center for the Culture DST laboratory for subsequent processing of samples for first-line line probe assay (LPA) and second-line drug resistance testing utilizing second line LPA and liquid culture DST
5. Recording and reporting including digitization of diagnostic process from collection to test result in NTEP Nikshay portal and Laboratory Information Management System
6. Management of supplies and logistic associated with laboratory logistic (CBNAAT cartridges and TrueNAT chips) and reporting any additional requirement thereof
7. Supporting the quality assurance activities undertaken by District or Intermediate Reference Laboratory under NTEP
8. Support health system in carrying out special drives for vulnerable and at-risk population and their testing directly by CBNAAT (slum population, diabetic population, smoker, malnourished people, patients of silicosis and kidney dialysis etc.)

Resources

• RNTCP Technical and Operational Guidelines for TB Control in India, 2016.
• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, 2021.

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Functions and Integrated Services of the DMC

• Testing of Sputum samples by Microscopy.
• Request/ referral for microscopy or Nucleic Acid Amplification Test (NAAT) or Culture and Drug Susceptibility Test (C&DST) or Chest X-ray (CXR) or Tuberculin Skin Test (TST) is generated at the PHI-DMC, as well as follow-up tests.
• Maintain consumables and logistics required for testing/ packaging and transport.
• Maintain TB laboratory registers for recording and reporting.
• Notify every TB patient in Nikshay at the earliest and update information of patients on comorbidity, treatment adherence, treatment outcome, contact investigation and TB Preventive Treatment (TPT).
• Biomedical waste management for the waste generated at DMCs.
• A DMC is required to participate in the External Quality Assurance system(EQA) of NTEP to ensure standardized quality diagnostic testing. 

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

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To increase access to diagnostic services, NTEP has a provision for sputum collection centres in areas where the health facility is not equipped with key requirements to conduct sputum microscopy, molecular tests, drug susceptibility testing or follow up examinations.

Sputum collection centres are dedicated locations where sputum samples are collected, packaged and then transported to nearby TB diagnostic centres. It could be attached to any near-by health-facility as well.

Requirements of a Sputum Collection Centre

To function as sputum collection centres, the following is essential:

• Linkage/ mapping (time and distance) to testing laboratory
• Availability of adequate number of sputum cups and falcon tubes, logistics for sample packaging and transport
• Identification of open areas for sputum collection
• Staff trained in NTEP guidelines on sputum collection, sample packaging and transport, complete and correct documentation of laboratory request form, and infection control practices
• Feasibility and financial measures required for sample transport
• Inclusion of local volunteers, courier services, sample transportation under National Health Mission Free Diagnostic Services or other mechanisms as decided by the state/district
• Availability of Information, Education and Communication (IEC) material, training modules, and job-aids
   

 Sputum collection centres are established in:

• Ayushman Bharat Health and Wellness Centres/Sub-centres
• Urban primary health centres
• Tribal, hilly, desert and difficult-to-reach areas of the country

Resources

• Training Modules for Programme Managers and Medical Officers
• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres
• Mycobacteriology Laboratory Manual, GLI Initiative, 2014

Assessment:

Screening for active tuberculosis (TB) a process to filter out people who are less likely to have TB, from a group. Screened positive people are likely to have TB and are confirmed subsequently using a TB diagnostic test. This will allow finite diagnostic testing resources to be used on the remaining.

Screening in TB may be performed ​using simple field tools (4 Symptom complex) and tests such as Chest X-ray, or a combination of both. ​Combination of both is the most effective, but is often not applied due to the practical difficulties in making a chest X-ray conveniently available.

Screening is an integral part of any general case finding effort. It is also applied systematically in specific situations.

1. At health care facilities (intensified case finding): Here those visiting are screened using the 4 symptom complex, often at the point of entry to the facility. Those screened positive may be fast-tracked to TB Diagnostic testing.
2. In vulnerable populations in active case finding efforts: Here the entire population identified for active case finding are screened using the pre-decided protocols by going door to door. 

Resources

• Systematic Screening for Active Tuberculosis; Principles and Recommendations, WHO 2013.
• National Strategic Plan for Tuberculosis Elimination 2020–2025.

People who have been exposed to patients with infectious TB are known as TB contacts; they constitute a high-risk group for TB. Case finding investigation contributes to the early detection of TB cases, and results in identifying a significant number of additional patients.

Figure: Approaches to Tuberculosis Case Finding

Active case-finding requires systematic screening and clinical evaluation of populations who are at high risk of developing TB, such as people living in slums, tribal areas, congregate settings, persons who are household contacts of TB cases

Resources:

• Assessing TB Case-Finding

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Systematic screening of all individuals of a defined population is known as active case finding.  It is applied outside of health facilities at the community level by the health system.

Objective of ACF is to:

1. identify cases early, initiate prompt treatment, reduce risk of poor treatment outcomes and reduce risk of further transmission of TB
2. to provide access to diagnosis services to populations that would have been otherwise unreached

It is effort intensive and is recommended only in population groups where there is estimated high case load. In NTEP, ACF is recommended only to be performed in Key / vulnerable population.

ACF can also be clubbed with suitable ACSM campaigns to create awareness about the signs and symptoms and about TB in the target population/ community. It can also be combined with other health activities/ campaigns (such as Pulse Polio/ Leprosy screening/ population based screening for NCDs) for increased efficiency.

Resources

1. Training Modules for Programme Managers and Medical Officers.
2. Active TB Case Finding, Guidance Document.
3. WHO recommendations for Systematic Screening for Active Tuberculosis

Assessment

Passive case finding is essentially where the patient self reports to the health care provider with symptoms. This requires that affected individuals are aware of their symptoms, have access to health facilities, and are evaluated by health workers or volunteers who recognise the symptoms of TB and link those individuals for TB testing services.

This approach to case finding has the least effort and cost and is a minimum expectation. In a Peripheral Health Institution (PHI), it is estimated that about 2-3% of new adult outpatients are symptomatic that require referral for TB diagnosis (presumptive TB cases).

Passive case finding may miss TB patients if :

1. The disease is mild/ transient.
2. Access to healthcare is poor.
3. Health providers do not have an adequate index of suspicion and are unable to reliably link respiratory symptoms to TB. 

Resources

1. Training Modules for Programme Managers and Medical Officers.

Assessment

Intensified Case Finding (ICF) is a case finding approach between Active and Passive approaches. Here individuals coming in contact with the health system through any activity are screened actively for symptoms of TB and referred for testing.

This approach brings the benefit of active case finding approach by active screening for TB symptoms, but does limit the extensive effort required by restricting to only those people who has some or the other healthcare problem. This approach is considered for people attending a healthcare facility.

Some examples of ICF are screening for TB symptoms and referral for testing in:

• all cases attending an HIV clinic.
• among children with malnourishment who attend a nutrition clinic.
• all mothers attending the antenatal clinics

Resources

1. Technical and Operational Guidelines.
2. Assessing TB Case Finding.

Assessment

Bidirectional screening is a method to identify cases in diseases which have predisposition to each other or has a significant influence on each other. For example TB and HIV, where having HIV increases risk of developing TB and cases with TB would have poor outcomes if co-infected with HIV.

Screening for TB is done through four-symptoms complex based screening or through Chest X-ray. Screening for the linked disease is carried out as per the policies of the corresponding health program.

Bi-directional screening policies are implemented by various disease control programs. For example, with NTEP the following disease control efforts implement a bidirectional screening policy:

1. HIV through NACO 
2. COVID19 
3. Diabetes Mellitus (DM) through NPCDCS
4. Tobacco  through National Tobacco Control Program

Both programs monitor bidirectional screening, referral and testing as per their own policies.

Resources

1. National Strategic Plan for TB Elimination.

Assessment

Why important, how is it done,

It is crucial to make an effort for microbiological confirmation in presumptive Extrapulmonary Tuberculosis (EPTB) cases. Appropriate specimens from the Extrapulmonary (EP) site are collected and, depending on the specimen type and availability of facilities, the specimens are sent for:

• Cartridge-based Nucleic Acid Amplification Testing (CBNAAT)
• Culture and Drug Susceptibility Testing (C&DST) for M. tuberculosis 
• Histopathological examination

The diagnostic algorithm (see the figure below) to be followed for EPTB cases depends on 2 main factors:

1. Availability of appropriate specimens from the EP site
2. Availability of CBNAAT (preferred test)

Figure: Diagnostic Algorithm of EPTB

• If an appropriate specimen from the EP site is available, specimens from the presumed sites of involvement must be tested with CBNAAT.
• CBNAAT detects MTB and RIF status and helps to identify microbiologically confirmed EPTB cases.
• If CBNAAT is not available, the specimen is sent for Liquid Culture (LC) at the C&DST lab. If the LC is positive, it is identified as a microbiologically confirmed EPTB case.
• If there is high clinical suspicion of TB even after a negative culture result, other diagnostic tools are used to clinically diagnose EPTB (usually with a specialist). If these tests indicate TB, they may be treated as clinically diagnosed EPTB or else arrive at an alternate diagnosis.

Clinical Diagnosis of EP-TB

If an appropriate specimen from the EP site is not available, in the presence of high clinical suspicion of TB, other modalities of diagnosis are used in consultation with a specialist. If with other diagnostic modalities, TB diagnosis still cannot be established, the specialist may explore an alternate diagnosis. 

A clinical diagnosis of EPTB is made if a consultative decision is made to treat with a full course of anti-TB drugs in spite of the situations listed above. Chest X-ray (CXR), ultrasonography, Computerised Tomography (CT) scan, Magnetic Resonance Imaging (MRI) and biochemical examinations are supporting tests that can be used to help arrive at a diagnosis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Technical Operational Guidelines, Chapter 3: Case Finding and Diagnosis Strategy, NTEP.

Assessment

​

Drug-resistant TB (DR-TB) diagnosis is predominantly based on laboratory diagnosis. Presumptive-TB/ DR-TB is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

The vision of National TB Elimination Programme (NTEP) is to provide early diagnosis to all persons with any form of DR-TB through Universal Drug Susceptibility Testing (UDST).

All diagnosed TB patients are eligible for a NAAT test to know their Rifampicin sensitivity status. The integrated diagnostic algorithm for diagnosis of TB offers upfront Nucliec Acid Amplification Test (NAAT) for diagnosis of TB to vulnerable population. Among other eligible groups for NAAT are: non-responders to treatment and contacts of DR-TB patients are also offered upfront NAAT.

Rapid identification of DR-TB is achieved by using a combination of NAAT (CBNAAT/ Truenat) followed by sequential testing by first- and second-line Line Probe Assay (LPA) and Liquid Culture (LC) and Drug Susceptibility Testing (DST) for specific drugs as described below:

• When Rifampicin resistance is not detected by NAAT, the patient is offered First-line (FL) LPA.FL-LPA provides information on Isoniazid resistance.
• For Rif resistance/Inh resistance cases, SL-LPA  is done and it provides information on resistance to Levofloxacin, Moxifloxacin and Amikacin.
• For all Rif resistance cases, LC and DST is done for Pyrazinamid, Moxifloxacin (if resistance detected by LPA), Linezolid, Clofazimine*, Bedaquiline* and Delamanid*.

(* when available)

Resources

• Guidelines for PMDT in India, 2021.

Assessment

Check

All childhood TB patients’ sputum and other relevant samples (e.g. gastric aspirate, induced sputum, bronchoscopic lavage, lymph node aspiration, CSF, tissue biopsies etc.) should be subjected to genotypic or the phenotypic Drug Susceptibility Tests (DSTs). Based on the bacteriological confirmation, the child should be treated for DS/DR TB as required.

But in cases where the child’s DST is unknown, the source patient’s DST should be considered.

If the source is a known DS TB, treat the child for DS TB. If the child responds poorly to the DS TB treatment consult the pediatrician and re attempt the necessary investigations.

If the source patient is a known DR TB patient, consult with the pediatrician and re-attempt DST on an appropriate specimen from the child and treat as per the child’s DST (if the report is conclusive), if not then treat the child as DR TB after the source patient.

If the source patient’s DST status is not known perform DST on the child’s and the source patient’s specimen and treat the child as per the DST of the child or the source patient, whichever report is conclusive.

Pediatric TB patients should be presented to and discussed with a DR-TBC Committee (including the pediatrician) to decide the treatment.

Image

Figure:  Diagnostic Algorithm for Paediatric DR-TB; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India,2021, CTD, MoHFW, India, p39. 

Abbr: DR-TB: Drug-resistant TB; DS-TB: Drug-sensitive TB; NAAT: Nucleic Acid Amplification Test; MGIT: Mycobacterium Growth Indicator Tube; DST: Drug Susceptibility Testing; DRT: Drug Resistance Testing; BAL: Bronchoalveolar Lavage.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis.

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Assessment

Based on the site of disease, Tuberculosis can be classified as-

1. Pulmonary tuberculosis (PTB) refers to any microbiologically confirmed or clinically diagnosed TB involving the lung parenchyma or the tracheo-bronchial tree.
2. Extra Pulmonary tuberculosis (EPTB) refers to any microbiologically confirmed or clinically diagnosed TB involving organs other than the lungs such as pleura, lymph nodes, intestine, genitourinary tract, joint and bones, meninges of the brain etc. 

Note: Miliary TB is classified as PTB because there are lesions in the lungs. A patient with both pulmonary and extra-pulmonary TB should be classied as a case of Pulmonary TB.

• New case - A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new case. 
• Previously treated patients have received 1 month or more of anti-TB drugs in the past. They could be further classified as:
• Recurrent TB case - A TB patient previously declared as successfully treated(cured/treatment completed) and is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. 
• Treatment After failure patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment.  
• Treatment after loss to follow-up A TB patient previously treated for TB for 1 month or more and was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB case 
• Other previously treated patients are those who have previously been treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented. 
• Transferred In: A TB patient who is received for treatment in a Tuberculosis Unit, after registered for treatment in another TB unit is considered as a case of transfer in.
• Transferred Out : A patient who has been transferred to another recording and reporting unit and whose treatment outcome is unknown.

Resources:

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021 
• WHO Consolidated Guidelines on Tuberculosis: Module 4-Treatment: Drug resistant TB Treatment, 2020

On the basis of diagnosis, Tuberculosis (TB) can be classified into 2 main types:

1. Microbiologically confirmed TB
2. Clinically diagnosed TB

Microbiologically Confirmed TB

• Microbiologically confirmed TB refers to a presumptive TB case from which a biological specimen is positive for acid-fast bacilli/ Mycobacterium tuberculosis on smear microscopy, culture, or on a rapid diagnostic molecular test (such as Cartridge-based Nucleic Acid Amplification Test (CBNAAT)/ Truenat).
• All such diagnosed cases should be notified at the source, regardless of whether TB treatment has started.

Clinically Diagnosed TB

• Clinically diagnosed TB refers to a presumptive TB case that is not microbiologically confirmed but has been diagnosed with active TB by a clinician who has decided to give the patient a full course of anti-TB treatment.
• This definition includes cases diagnosed on the basis of X-ray abnormalities or suggestive histology or extrapulmonary cases without laboratory confirmation.
• Clinically diagnosed cases subsequently found to be microbiologically positive (before or after starting treatment) should be reclassified as microbiologically confirmed.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Definitions and Reporting Framework for Tuberculosis, WHO, 2013.

Assessment

Active Case Finding (ACF) is a provider-initiated activity with the primary objective of detecting TB cases early by active case finding in targeted groups and to initiate treatment promptly.

• It can target people who anyway would have sought health care with or without symptoms or signs of TB and also people who do not seek care.
• Increased coverage can be achieved by focusing on clinically, socially and occupationally vulnerable populations.
• ACF activities in a campaign mode will create mass awareness about the signs and symptoms in general population

Objective of ACF campaign activities- Reaching the unreached in a campaign mode to enhance TB case finding

Figure 1: Objectives of active case finding

Beyond TB disease, screening can also identify individuals who are eligible for and would benefit from TB preventive treatment (TPT) once TB disease is ruled out, thus further averting future incident TB.

General process is as below:

Figure 2: ACF campaign general process

Resources

1. WHO consolidated guidelines on tuberculosis: Module 2: Screening, Systematic screening for TB disease;WHO 2021
2. India TB Report 2022, Central TB Division, MoHFW 2022
3. Active TB Case Finding- Guidance document, Central TB Division & DGHS, MoHFW 2017

Assessment:

Mapping of vulnerable population is a pre-requisite for conducting an efficient ACF campaign. It involves understanding the population characteristics, identifying and enumerating and mapping the target population. 

Guidelines for mapping

• Identify & map high risk/ vulnerable populations in the local area with the following guidance. If additional information is available locally, it can be used for the prioritisation of target groups.

Figure 1: Schematic map for house to house survey of identified vulnerable population

• Without proper mapping, there is a high chance of missing cases. The success of the active TB case finding campaign relies on how good the mapping is.

Resources

• Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017.

Assessment

Active case-finding (ACF) approaches bring essential TB services closer to the community. It has high potential for improving TB case detection and reach people with TB currently missed by the health system. To maximize gains from ACF, it is important that the interventions are planned in advance. 

Planning for ACF includes identifying the right target population/area, designing the intervention, finding the right implementing partners, training of workforce, microplanning for daily activities, logistics, ensuring that the complete pathway of care is followed, reporting and recording.

Steps involved in planning for ACF

1. Identification of population based on:

a. increased risk for TB eg: prisoners, miners, urban slums, co-morbidities like HIV, diabetes etc.

b. those with limited access to health services eg: migrants, homeless, tribal, live in hard to reach areas etc.

2. Identification of stakeholders including district and sub-district TB program staff, non-government organizations, community based organizations, community health workers to support with ACF activities

3. Strengthening the health system e.g. training of staff, ensuring sufficient lab supply and lab technicians. Staff trainings should be done to eliminate gaps in knowledge about TB, cough hygiene, infection control measures, conducting screening, collecting quality sputum, transporting sputum or referring people with presumptive TB to the health facility/laboratory, TB testing, data collection, data entry 

4. Microplanning for ACF includes:

a. when and where to conduct ACF-day, time, duration, methodology-camp, door-to-door, community gatherings, home visits, place of work etc

b. availability of trained manpower, team composition, logistics and consumables

c. screening and diagnostic algorithm to be used

d. number of screenings and tests done per day

e. accessibility and linkage with TB testing laboratories, use of mobile van with CXR, CBNAAT/Truenat 

f. laboratory workload to accommodate additional testing due to ACF

g. laboratory turn around time, availability of test reports for clinical management 

h. advocacy on ACF activities with the target population, pre-sensitization meetings, addressing perceived risks of TB screening and diagnosis (e.g. job loss, loss of income)

i. data collection tools (paper based, smartphones, tablets etc.), TB notification, recording and reporting

Resources

1. Systematic screening for active tuberculosis: an operational guide (http://www.who.int/tb/publications/ systematic_screening/en/)

2. Experience of active tuberculosis case finding in nearly 5 million households in India (Prasad BM, Satyanarayana S, Chadha SS, Das A, Thapa B, Mohanty S, et al. Public Health Action. 2016;6(1):15–8. doi:10.5588/pha/15/0035)

3. Community-wide screening for tuberculosis in a high-prevalence setting (Marks GB, Nguyen NV, Nguyen PTB, et al. N Engl J Med 2019; 381: 1347-57)

Assessment

A state-level meeting by the Principal Secretary of Health & Family Welfare with all members must be held to communicate the days of the Active Case Finding (ACF) campaign and take all the necessary actions needed to conduct a successful campaign in the state.

Training for ACF is given in a top to bottom manner as follows:

I. State-level training workshop

• One-day training workshop for District and Sub-district level officers will be conducted. 
  
  • Trainers - State TB Officers (STOs), State TB Training and Demontration Centre (STDC) in charge, National TB Elimination Programme (NETP) Consultants, Central representatives
  • Trainees - District TB Officers (DTOs), Block/ Municipal Medical Officers, Senior Treatment Supervisor (STS), Senior Treatment Laboratory Supervisor (STLS), Non-government Organisation (NGO) partners, etc.
• The objective of the workshop should be to sensitise the district & block level planners on the strategy to be followed, the need for preparing micro-plans for their areas, and sort out issues of coordination between the implementing partners.
• Training to suspect the TB cases in the community, collection/ transport of sputum samples and recording/ reporting of daily activities should also be given.

II. District micro-planning meeting/ Urban area planning meeting

• The Chief Medical Officers (CMO) / DTOs/ National TB Elimination Programme (NTEP) consultants and the NTEP field staff, should facilitate these meetings.
• The meetings have to be attended by all block/ municipal medical officers, and other organisations involved in social mobilisation, along with personnel involved in planning at the block level.
• The objective of these meetings should be to sensitise the Block Medical Officers (BMOs) on how to micro-plan for their areas for the upcoming ACF campaign. Special attention should be paid to developing area-specific Information, Education and Communication (IEC) strategies for difficult areas.

III. Orientation trainings at block/ ward level for Accredited Social Health Activists (ASHAs)/ Field Level Workers (FLWs)/ NGO staff

• Trainers - DTOs, block/ municipal medical officers and NTEP consultants (wherever available)
• Trainees - ASHAs and local volunteers. Concerned supervisors of the team must also present during these orientation trainings.
• The objective of the trainings would be to build the capacity of all the field level workers (ASHA & FLW) to suspect TB cases in the community, collect/ transport sputum samples and record/ report daily activities.
• The orientation will cover the operational as well as the Interpersonal Communication (IPC) aspects of the ACF campaign.
• The instruction sheet for the search team, recording/ reporting tools, sputum collection & transportation methodologies, and Frequently Asked Questions (FAQs) should be distributed and discussed during this orientation.
• Demonstration of recording/ reporting tools and house markings followed by exercises for ensuring all operational skills as also role plays on IPC and FAQs should form an essential component of all FLW/ ASHA training sessions.

References

• Active TB Case Finding Guidance Document, 2017, Central TB Division, Ministry of Health and Family Welfare.

Assessment

A good screening algorithm should have the following characteristics:

• High specificity (to reduce the number of false positives, ideally around 70%)
• High sensitivity (to reduce the number of false negatives, ideally around 90%)
• Low Number Needed to Screen (NNS)
• Low cost
• Rapid and simple to apply
• High client acceptability

The algorithm should be optimised so that the maximum number of cases can be detected with available resources.

Usually verbal screening using  symptom complex (4S) are used. However ACF campaigns targeting high risk populations (household contacts, elderly homes etc.)can consider using X ray also as a screening tool. Chest X ray helps in picking up sub-clinical TB cases also which will be usually missed through verbal screening of symptoms.   

A more sensitive test like NAAT is preferred over sputum microscopy in ACF campaigns as the cases will be in early stage and may be missed by testing using Microscopy.

References

• Optimising Active Case Finding – Implementation Lessons from South-East Asia. WHO SEAR, 2021.
• WHO Consolidated Guidelines on Tuberculosis – Module 2: Screening, WHO, 2021.
• High-priority Target Product Profiles for New Tuberculosis Diagnostics: Report of a Consensus Meeting, 28–29 April 2014, Geneva, Switzerland. Geneva: World Health Organisation, 2014.

Assessment

1. Financial Resources

• Financial resources for ACF may be procured from the Centre/State or through local Private Provider Support Agencies (PPSA). When the funds for ACF are procured from the centre, it should be included under a separate budget head (DSTB Pool) under PIP. 
• Each team would be eligible for an incentive of INR 500 for every new case of TB diagnosed and put on treatment under this activity OR as per approvals in the Programme Implementation Plan (PIP) in the National Programme Coordination Committee (NPCC) of the respective state or as approved by the state National Health Mission (NHM). 
• Each state should ensure that local travel arrangements from the general health system are made available for the field visits by the team, supervisory visits, etc.
• Allowances to ensure Travel Allowance (TA)/ Dearness Allowance (DA) and refreshments as per entitlement are to be made from the respective source of salary for the field teams and supervisory teams.

2. Consumables

Logistics for an ACF campaign include:

a. IEC materials: Appropriate IEC materials are to be designed and printed in the local language. A prototype of the same will be shared with states from the CTD. IEC material printing/ distribution should be completed by two weeks before the start of field activities.

b. Additional logistics for testing:

• Additional slides, laboratory reagents, sample transport boxes, X-ray films, CBNAAT cartridges,  falcon tubes (minimum 1000 per 1 lakh population) should be procured and supplied to health staff for collecting sputum samples from the eligible symptomatic at least two weeks before the start of field activities. Boxes for sputum sample transport should be provided to the health staff for carrying samples to DMCs.
• Additional sputum examination request forms needed – 500 per 1 lakh population

c. Recording and reporting forms: All recording and reporting formats requirement assessment is to be done by DTOs three weeks before the start of field activities

3. Human resource

Human resource for ACF is required for the following:

a. Field activities: House-to-house visits, symptom screening, sputum collection and transport to the Designated Microscopy Centre (DMC).

• One field visit team will comprise two members - one health worker from National TB Elimination Programme (Senior Treatment Supervisor (STS)/ Senior TB Lab Supervisor (STLS)/ TB Health Volunteer (TB-HV)) or a partner organisation (NGO outreach worker) or general health services (Auxiliary Nurse Midwife (ANM)/ Multipurpose Worker (MPW)/ Multipurpose Healthcare Supporters (MPHS) and one Accredited Social Health Activist (ASHA) or community volunteer. The states should decide on the team composition based on available resources and the population to be covered (as obtained from vulnerability mapping).
• House-to-house visits by health workers should involve community leaders, panchayat members particularly the women members, religious leaders and other local influencers like medical practitioners, local moneylenders, grocery shop owners, popular teachers, prominent youth, etc.
• Local community members/ influencers must accompany search teams during house-to-house visits in such areas, especially during revisit to houses.

b. Testing additional sputum samples for Mycobacterium tuberculosis (MTB): Laboratory technicians of the linked DMC and Cartridge-based Nucleic Acid Amplification Test (CBNAAT) labs should be well-informed about the increase in workload and recording of information during ACF activities. 

c. Supervision and Monitoring of ACF activities: Supervision and monitoring of the campaign are done at various levels under the leadership of designated officers. It is  required during the preparatory phase as well as the implementation phase of the campaign.The list of observers along with the districts/ blocks/ urban areas allotted must be shared with Central TB Division (CTD).

• Village level - Medical Officer of Primary Health Centre (PHC)/ Community Health Centre (CHC)/ Urban Health Centre (UHC)
• Block level - Block Medical Officer (BMO)/ Block Health Officer (BHO)
• District level - District TB Officer (DTO)
• State level - State TB Officer (STO)
• Regional level – Regional Directors of the Regional Office of Health and Family Welfare (ROH&FW) will be in charge of supervising activities in their respective states.
• National level - One national level officer for each state will be nominated by CTD to supervise and monitor activities including field visits to the states prior to and during the campaign.

References

• Active TB Case Finding Guidance Document, Central TB Division, Ministry of Health and Family Welfare, 2017.

Assessment

Microplanning for ACF Campaign

A microplan is a detailed plan of action in terms of human resources, materials, money and time. A good microplan ensures that the health intervention reaches each individual beneficiary and is crucial to the success of the activity. For Active Case Finding (ACF), microplanning is performed at the health facility level and collated at the block, district and state levels. Training for the same is given to concerned personnel during state, district and block level meetings prior to the campaign. Microplan at PHI, Block, District and State levels should be ready at least 15 days prior to the initiation of field activities.

Microplanning is done with respect to:

I. Advocacy, Communication and Social Mobilization (ACSM)

 A comprehensive IEC plan should be made with communication material for mass media, mid-media and print media to reach out up to the remotest village in advance.

II. Logistics

• Microplan should include planning additional consumables required for the campaign
• It includes additional slides, laboratory reagents, sputum cups, falcon tubes, sample transport boxes, X-ray films, Cartridge-based Nucleic Acid Amplification Test (CBNAAT) cartridges, etc. Additional sputum containers (minimum 1000 per lakh population) will be procured and supplied to health staff for collecting sputum sample from the eligible symptomatic two weeks before the start of field activities
• Linkages of Peripheral Health Institute (PHI) areas with Designated Microscopy Centre (DMC), X-ray facilities, CBNAAT lab, Extra Pulmonary (EP) sample collection and EP testing should be included in the planning up-front. 
• Laboratory technicians of the linked DMC and CBNAAT labs should be well informed about the increase in workload and recording of information during ACF activities.

III. Field activities including human resources

• Maps prepared for other campaigns like Pulse Polio, Leprosy Case Detection Campaign (LCDC), etc. must be used while planning. If maps are not available with local bodies, search team members and supervisors should be sent to the area before the ACF campaign, in order to become familiar with the area and develop maps. 
• The number of houses to be covered each day should be mentioned in the microplan. This number may vary from day to day depending upon the geographical situation of the area planned to be covered by the team on a particular day. 
• Teams of two persons each should go house-to-house. Out of the two members in each team, one should be a local volunteer (including Accredited Social Health Activist (ASHA)).
• Each team should be allocated clear-cut, well-demarcated areas clearly mentioning the starting and ending points, identifiable with landmarks; for each day of House to House (h-t-h) activity.
• In special areas, one additional person from the local community, where the team will be working, should accompany the team. 
• Human resources required for covering the mapped vulnerable population during field activities should be calculated and recorded.
• For planning and implementation purposes, urban areas should be divided into smaller planning units based on municipal wards or assemblies, or by roads or prominent landmarks. Each such unit should be put under the charge of a medical officer or nodal officer.
• Involvement of the local community, leaders, health officials, municipal bodies and their staff is essential in planning.
• Local staff is familiar with the layout of the urban areas and their inputs are vital for planning and supervision of house-to-house activities.

Execution of Microplan

The ACF campaign is executed as per the microplan and supervision is done with reference to the microplan

The House to House (h-t-h) survey is done for 2 weeks

A survey team consisting of 2 persons - one NTEP staff/ partner organization staff/ General Health services staff and one local volunteer / ASHA worker. They go from house to house in the mapped vulnerable areas/ key population groups and screen individuals for symptoms of TB. After screening, the eligible population for sputum examination includes: Persistent cough for ≥2 weeks, Fever for ≥2 weeks, Significant weight loss (>5% weight loss over last 3 months), Presence of blood in sputum any time during the last 6 months, Chest pain in the last one month, History of Anti-TB Treatment (previous/ current). If any one of these is present, a sputum cup or falcon tube is given to them and a sputum sample is collected. Sputum samples thus collected are transported to a designated lab using the sample transport system existing in the area. testing using smear microscopy/CBNAAT will be done for all symptomatic persons as per the state policy. Those who are microbiologically confirmed to be positive should be initiated on treatment within 2 days. Additionally, the team will look for other symptoms/diseases also. If person is having any symptoms or other ill health, s/he will be referred for evaluation by a Medical Officer for further management, if needed. Field Activity Report will be submitted by each health staff on a daily basis to the Medical Officer of the Peripheral Health Institution

Resources

• Active TB Case Finding – Guidance Document, 2017, Central TB Division, MoHWF, New Delhi.
• Active Case Finding for Tuberculosis in India: A Syntheses of Activities and Outcomes Reported by the National Tuberculosis Elimination Programme, Burugina Nagaraja S et al, Trop Med Infect Dis., 2021.

Assessment

Vulnerability mapping and Microplanning are 2 important activities of Active Case Finding which precede field activities. Vulnerable populations should be mapped and recorded in prescribed formats from health facility level onwards. Mapping data from PHI are consolidated at Block level, those at Block level are consolidated at district level and those at district level are consolidated at state level. Data from mapping formats is used for microplanning. Microplanning forms the basis of field activities. Microplans are also consolidated at subsequent levels. During supervision and monitoring, it is important to assess the activities with respect to the microplan. 

The recording formats for ACF include:

1. Formats for mapping - Health Facility Level, Block Level, District Level and State Level                     

2. Formats for microplanning - Manpower, Logistics, Field Activity

FORMATS FOR MAPPING

Mapping details should also be entered in Ni-kshay under the section shown below:

Image

Fig: Ni-kshay section for reporting various ACF activities

FORMATS FOR MICROPLANNING

Based on the requirement obtained from the mapping exercise, microplanning is done with respect to human resource, logistics and field activities

Human Resource Planning Form

Field activities are captured in Form 1 & 2 of the ACF. The data from field activities are compiled at the PHI level and submitted to the District and State using google sheets at present. Although there is no specific mechanism to demarcate the presumptive TB patients and the confirmed (clinical and microbiological) TB cases in Ni-kshay, States follow different mechanism including marking in the Laboratory register as ACF testing and sending a separate sheet to the district in paper format.

Reference: 

1. Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017 

Assessment:

Field supervision of Active Case Finding (ACF) is needed during both the preparatory phase and the implementation phase. Supervisory teams should be formed at the National, State, District, Block and Peripheral Health Institute (PHI) levels.

Field supervision during the preparatory phase: 

The Field Supervisors should: 

• Attend District and Block Coordination Committee meetings.
• Review the micro plan and check whether all components are present. 
  • All geographical areas have been included. 
  • Team composition is appropriate – all house-to-house teams have at least one Accredited Social Health Activist (ASHA) and at least one Non-government Organisation (NGO) worker and at least one National TB Elimination Programme (NTEP) field staff. 
  • Sensitisation training to detect the cases has been planned for all ASHAs and field staff. 
  • Workload of teams in terms of houses to be covered/ day has been rationalised.  
  • Areas requiring special attention have been identified and plans developed.
  • Information, Education and Communication (IEC)/ social mobilisation plans have been developed and documented. 

Field supervision during the implementation phase: 

• All officers should again visit their allotted districts/ blocks/ urban areas during the implementation phase to assess the quality as well as the completeness of coverage of the area through house-to-house visits. 
• Field Activity Report will be submitted by each health staff on a daily basis to the Medical Officer of PHI. The Field Activity reports from all health staff will be analysed and appropriate action will be taken by the Medical Officer of PHI and these reports will be combined and a report will be prepared and submitted to Block Medical Officer (BMO) on daily basis. 
• Ensure a mechanism of daily feedback from the observers to the block and district control rooms to facilitate immediate corrective action at all levels. Tracking the cascade of care is a useful tool for assessing quality. (Cascade of care: Track No. of people targeted, no. of people screened out of targeted, no. of presumptive TB identified out of screened, no. of presumptive TB patients examined out of identified, no. of presumptive TB completely evaluated {like smear-negative patients examined with chest X-ray and Cartridge-based Nucleic Acid Amplification Test (CBNAAT), no. of TB patients diagnosed out of examined, no. of TB patients put on treatment out of those diagnosed.})
• Qualitative and quantitative assessment of the ACF campaign activity from observers should be utilised for long-term corrective actions like problems faced by ASHAs & Frontline Workers (FLWs) during the campaign, review of micro-plans etc. or immediate corrective actions like repeating the activity in an area where a significant number of uncovered houses are found after completion of the activity. 

The Progress indicators and quality indicators for ACF should be monitored by the supervisory team while on field visit.

Resources

• Active TB Case Finding Guidance Document, CTD, DGHS, MoHFW, 2017.

Assessment

Monitoring should be an integral part of the Active Case Finding (ACF) interventions. It is accomplished by a strong data collection system enacted through a programme-based ACF data and recording in Nikshay.

Monitoring activities for ACF interventions broadly cover the number screened, number of presumptive TB cases based on symptoms or chest X-ray findings, samples collected for testing, samples transported for testing, samples tested, microbiologically and clinically diagnosed TB cases, TB notification and treatment initiation.

Monitoring Against the ACF Plan

1. Monitor the Number Needed to Screen (NNS), i.e., the number needed to be screened based on current TB symptoms, past history of TB, comorbidities, other socio-economic factors, etc. 

2. Monitor the Number Needed to Test (NNT) which helps understand the efficiency of diagnostic testing and the efficiency of screening for presumptive TB.

3. Monitor the yield of ACF activities, i.e., TB cases found and compare the yield of different screening and testing methods (X-ray, smear, Nucleic Acid Amplification Test (NAAT)).

4. Monitor whether there was an additional increase in TB notification of bacteriologically confirmed TB cases compared to the previous year (or in comparison to a control district).

• Monitor notification trends, treatment outcomes and mortality (TB prevalence should decrease over years based on repeated ACF in the same population).

5. Monitor engagement of National TB Elimination Programme (NTEP) staff, non-governmental organisations, community volunteers and the private sector in ACF activities.

Monitoring Against the Cascade of Care

1. Monitor the proportion of people with presumptive TB who provide sputum.

2. Monitor linkage to health facilities, sample collection, transportation and tests done.

3. Monitor drop-outs between screening and diagnosis, dropouts between diagnosis and treatment.

4. Monitor public health action provided to notified TB cases.

Resources

• Optimizing Active Case Finding for Tuberculosis, 2021. 
• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.

Assessment

The ACF campaign has to be reported for documentation, monitoring and evaluating the performance of the activity and guiding the policy decisions. 

The various formats used for reporting of performance of Active Case Finding (ACF) activities are as follows:

1. Field activity daily report

• Submitted by each health staff on a daily basis to the Medical Officer of Primary Health Centre (PHC)/ Community Health Centre (CHC)/ Urban Health Centre (UHC).

Table 1: Format for field activity daily report

2. ACF activity reporting by Health Facility

• The Field Activity reports from all health staff will be analysed and appropriate action will be taken by Medical Officer of PHC/ CHC/ UHC.
• These reports are combined and a report will be prepared as per the following format and submitted to Block Medical Officer (BMO)/ Block Health Officer (BHO) on daily basis.

Table 2: Format for ACF activity by health facility

At the block level reports from all the reporting units will be compiled in the below format and sent to the District on a daily basis.

3. ACF activity reporting by Block/ Town/ City

Table 3: Format for ACF activity reporting by block/ town/ city

And at the district level, reports from all blocks are to be compiled in the format below, and the consolidated report should be sent to the State.

4. ACF activity reporting by District

Table 4: Format for ACF activity reporting by district

5. ACF activity reporting by State

Table 5: Format for ACF activity reporting by state

• State TB Officer (STO) would be responsible for the overall coordination and implementation of campaign activities and reporting in the State/ UT.
• Data entry of district-level reports in electronic format will be ensured by District TB Officer (DTO) on a daily basis after the field activity is completed. Nikshay has a section on active case finding where the mapping of target population and reporting of various activities can be done.

Fig 1: Nikshay section for reporting various ACF activities

Resources

• Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017.

Assessment

Three things are received by the Lab Technician- Sample for testing, request form, and  request for test in Nikshay.

Accepting the request for testing includes the following steps:

1. The LT verifies details on the request form that has eleven parts.

• The first part contains details on the name of referring facility, name of the patient, complete address, age & gender of the patient, date of referral, type of presumptive TB, the key population to which the patient belongs and site of disease.
• The second part contains details of referring facilities, Nikshay ID, and the names of State, district and TB units.
• The third portion is for the diagnosis and follow-up of TB.
• The fourth portion is for the diagnosis and follow-up of drug-resistant TB.
• The fifth portion is to indicate the required tests with the details of the person requesting the test.
• Parts six to eleven are used for reporting test results.

2. The LT verifies the quality of the sample received.

3. LT captures details on the patient, reasons for testing, test requested, and the visual appearance of the sample in the TB Laboratory register.

4. LT verifies the test request generated in Nikshay against the test ID requested (Figure).

Figure: Test Details Added in Nikshay by the Referring Health Facility; Source: Guidelines for PMDT in India, 2021.

5. LT initiates the test requested.

Resources

• Guidelines for PMDT in India, NTEP, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, NTEP, 2020.

Assessment

Presumptive pulmonary TB patients are subjected to sputum smear microscopy (Ziehl Neelsen (ZN)/ Florescence Microscopy (FM)). Two consecutive sputum specimens will identify the vast majority (95–98%) of smear-positive TB patients

Two specimens are collected:

• One Spot and one early morning sample OR
• Two supervised spot specimens collected at least one hour apart, and smears made from both the samples.

If one or both smears are positive, the patient is diagnosed as a microbiologically confirmed pulmonary TB case.

• The spot specimen collected is labelled as 'a'.
• While the patient is given a labelled container with instructions to cough out sputum into the container early in the morning after rinsing the mouth with water. This is the early morning specimen. This is labelled as specimen 'b'.

• If the health facility is not a Designated Microscopy Centre (DMC), then the patient is given a sputum container with the instructions to collect an early morning specimen and go with the sputum specimen to the DMC where the spot specimen can be collected.
• In case the patient is not able to travel to the DMC, then the spot specimen could be collected at the nearest health facility or sputum collection centre and transported to the DMC.
• These two samples should be collected within a day or two consecutive days.
• Two supervised spot samples may be collected one hour apart if patient is too sick, coming from a long distance or likelihood of not giving a second sample is significant.
• Collection of early morning specimens is preferred because of the overnight accumulation of secretions. However, spot samples collected at any time for patients is also suitable if productive sputum is expectorated after deep cough.

Resources

1. Module for Laboratory Technicians.
2. Training Modules for Programme Managers and Medical Officers.

Assessment

Educating patients on collection is essential to have good quality sputum. The healthcare worker (HCW)/ medical officer (MO) or the laboratory technician (LT) can educate patients on how to collect and dispense sputum.

The HCW/MO/LT provides a new sputum cup with the Laboratory Serial Number written on its side to the patient. They should explain that sputum should be collected in an open place or in a well-ventilated room; it should not be collected in closed rooms, toilets and ill-ventilated rooms

A specimen collected under supervision is likely to yield better results. Supervising person has to demonstrate how to collect good sputum and dispensing it:

1. Using a laboratory sputum cup, demonstrate how to open the lid of the specimen container and place it conveniently within their reach, so they can close it immediately after collecting sputum and also how to screw the cap on the cup tightly so it doesn't leak.
2. Demonstrate how to bring up sputum, beginning with rinsing their mouth as food particles may give false positive results.
3. Demonstrate deep inhalation (2–3 times) and let the patient know that this will initiate the cough reflex in most individuals.
4. Demonstrate how individuals can place their palms on the waist, squat or sit and continue deep breathing again. Tapping or thumping of the back 
   may encourage expectoration (Sitting and placing hands on the waist fixes the shoulder and pelvic muscles and brings the intercostal muscles of ribcage and diaphragm into action)
5. After deep inhalation and coughing deeply, the sputum should come up in their mouth. The sputum is retained in the mouth and allowed to fall from their tongue into the pre-labeled container. Patient should be encouraged not to spit into the container. The patient can also be encouraged to cough directly into the cup.
6. The patient’s mouth should not touch the container and the patient must ensure that sputum does not touch the outside of the container.
7. The patient should not open the sputum cup till they are ready to use it
8. They should not rub off the number written on the side of the container
9. They should not touch the inside of the container with their fingers or tongue while collecting sputum

The person collecting the specimen should make sure that no one stands in front of the individual who is trying to cough up the sputum. When an individual has only coughed up saliva or has not coughed up at least 2 ml of sputum, they should be encouraged to give good specimen that is of appropriate quantity.

Resources

• Module for Laboratory Technicians
• Training Modules for Programme Managers and Medical Officers

Assessment

The Healthcare Worker (HCW) needs to carefully explain how to collect a good quality sputum specimen. He/she needs to demonstrate how to bring up sputum from the chest, what a good sputum specimen looks like, and the quantity of sputum required.  

Characteristics of a Good Sputum Sample 

• Thick (semi-solid) muco-purulent (yellowish) in consistency, coughed out deeply from the lungs
• Sufficient in amount i.e., 2 to 5 ml (or enough to cover the size of a fingernail at the bottom of the container)
• It should not be blood-stained (brownish colour) as far as possible.

Steps to Ensure Good Quality Sputum Sample

1. Explain to the patient the characteristics of sputum - that it is thick and mucoid as compared to saliva which is thin and watery.
2. The patient should preferably rinse his/her mouth to get rid of any food particles which may give false-positive results.
3. One should demonstrate to the patient by action how s/he should take deep breaths and bring up the sputum.
   1. The patient is instructed to inhale deeply (2–3 times), which will initiate the cough reflex in most patients.
   2. The sputum is retained in the mouth and spit into the pre-labelled container without spilling.
4. Some patients may not be able to expectorate with deep breathing, in which case HCW should demonstrate to them how they should place their palms on the waist, squat or sit and continue deep breathing again.
   1. Tapping or thumping of the back may encourage expectoration. (Sitting and placing hands on the waist fixes the shoulder and pelvic muscles and brings the intercostal muscles of the ribcage and diaphragm into action).
5. When a patient has only coughed up saliva or has coughed up less than 2 ml (the size of a fingernail at the bottom of the container) of sputum, the patient should be encouraged to provide a better specimen.

Resources

• RNTCP Module for Laboratory Technician, CTD, MoHFW, 2005.

Biological specimen/ samples collected on reaching a TB testing laboratory needs to be formally received. The sample may be handed over by agents(couriers, health staff/ volunteers, patient representatives) or by patients themselves. The formal receipt of sample enables further processes such as testing and communication of results back to the patient. If the sample is successfully received, the appropriate testing process is initiated using the sample, else it is rejected and a fresh sample requested. 

The designated Lab Technician (LT) at the Laboratory is responsible for receiving the sample. To initiate the receipt, the sample along with the patient, or the sample along with accompanying test request is required. If it is available, following are the steps to complete sample receipt:

1. Compare patient information (Patient Name and Patient ID / Sample ID/ Test ID) to the test request that has been made.
   • This is performed by searching the patient ID in Nikshay under the Diagnostics menu and comparing and matching the patient details and the label on the sample.
   • If a physical form (Request for examination of Biological specimen for TB) is available, the details on the sample label and form needs to be compared and matched as well.
2. If the details are matched the LT then checks the quality (mucopurulent, non-blood stained), quantity (adequate to perform the requested test) of the sample and ensures that there is no leakage.
3. If the above checks are passed, then the LT Accepts sample. If not the LT rejects sample with a request to get a new sample. The rejection of the sample and request to obtain a new sample is recorded on Nikshay and is communicated to the patient and the person who requested the test.  
4. To register the receipt by accepting/Check in the sample for testing in Nikshay. The relevant information may also be captured in the TB Laboratory Register.  Ensure that the Test ID (if not already present) / Lab serial number from the Lab register is labelled on the sample container.

Sample receiving in Nikshay

Figure: Sample Journey Tracking in Nikshay; Source: Nikshay Diagnostic Training Content.

Resources

1. Training Modules (1-4) for Programme Managers and Medical Officers, NTEP, 2020.
2. Nikshay Zendesk, Nikshay Knowledge Base, FAQs.
3. Nikshay Zendesk, Nikshay Knowledge Base, Diagnostics.

Assessment

Storage conditions of sputum sample can effect the test results.

• Sputum samples should be transported to the laboratory as soon as possible after collection.
• It is the responsibility of Laboratory Technician (LT) and Senior TB Laboratory Supervisor (STLS) to ensure proper storage and transport of sputum specimens.
• Sputum is stored to preserve the specimen quality.
• The stored sputum samples should not be frozen.

Storage of Sputum Samples

For microscopy

• For smear microscopy, sputum specimens should be examined on the same day and not later than 2 days after collection.
• If delay is unavoidable, the sputum collected should be stored in a cool place/ refrigerated at 4°C to inhibit the growth of unwanted microorganisms.
• Stored sputum samples should be protected from light and heat to prevent liquefaction of the sample, else it makes the selection of mucopurulent part of the sample difficult.
• Samples received over holidays/weekends should be stored in a cool place/ refrigerated at 4°C.

For liquid culture

• Sputum should be stored in a cool place/ refrigerated at 4°C to inhibit the growth of unwanted microorganisms; not later than 3 days after collection.

For molecular tests - Nucleic Acid Amplification Test (NAAT) and Line Probe Assay (LPA)

• Sputum must be stored by refrigerating at 4°C to inhibit the growth of unwanted microorganisms and transported in cool chain to the nearest molecular laboratory. It should not be stored beyond one week at 4°C.

Resources

Technical and Operational Guidelines; Chapter 3: Case finding and diagnosis strategy

PMDT Guidelines 2021

Assessment

Sputum smears must be prepared promptly after samples are collected or received in the laboratory.

Steps in smear preparation are as follows:

1. Cleaning and Labelling of slide (No 1)
2. Making the smear (No 2-3)
3. Drying and Heat fixing the smear (No 4-5)
4. Staining and counterstaining the smear (No 6- 12)
5. Examination of slide/Reading the Smear (No 13-14)
6. Reporting and recording the observations (Digitally and TB Lab register)
7. Storage of slides (as per Laboratory Numbers in closed box) (No 15)

Figure: Steps in Smear Preparation; 1- Labelling of the slide, 2- Using a broomstick to pick up purulent portion (A) while avoiding the salivary portion (B), 3- Spreading sample on a glass slide, 4- Air-drying the slides, 5- Heat-fixing the smeared slides,6- Staining with 1% Carbol fuchsin, 7- Heating of stained smear, 8- Decolorize with 25% Sulphuric acid, 9- Rinse off decolourizer, 10- Counter stain with 0.1% Methylene blue, 11-Rinse off counter stain, 12-Drying the prepared slide, 13-14 Examination of smears , reporting of observations, 15-Storage of slides; Source: Laboratory Diagnosis by Sputum Smear Microscopy.

Resources

• Laboratory Diagnosis by Sputum Smear Microscopy - The Handbook, GLI, 2013.
• Module for Laboratory Technicians, CTD, 2005.

A Laboratory Serial Number is assigned to each presumptive TB patient who is examined at the microscopy centre.

Each Laboratory Technician (LT) needs to ensure that all the slides are labelled using the Laboratory Serial Number. This is essential for recording as well as for the review of the slide during the supervisory visit as well as during the quality assurance exercise.

For every test, a new slide needs to be used. It is essential that there are no fingerprints or any scratches on the side of the slide (see figure 1).

Figure 1: Always select new, clean, grease-free and unscratched slides

Once the LT is ready to prepare a smear, he/she needs to write the Laboratory Serial Number on the left side of the slide with a diamond marker or a grease pencil only (see figure 2). Avoid multiple labelling (see figure 3).

Figure 2: The laboratory serial number is written on one end of the slide using a diamond marker

Figure 3: Avoid Multiple Labelling; a grease pencil has been used to label the slide.

Labelling of slides needs to be monitored and supported by the concerned Senior TB Laboratory Supervisor (STLS) during External Quality Assessment (EQA) visits.

Resources

• RNTCP Module for Laboratory Technician, CTD, MoHFW, 2005.

Kindly provide your valuable feedback on the page to the link provided HERE

The National TB Elimination Programme (NTEP) has a standard procedure for sputum smear preparation, the steps for which are listed below:

The tools required for smear preparation include a clean work surface, new and clean glass slides, a discard bucket or a foot-operated bin with a plastic liner, bamboo or wooden applicator sticks or sterile wire loop, spirit lamp and a rack for drying smears.

• Use new, clean, unscratched glass slides and label the slide with the laboratory serial number. 
• Prepare the smear in the centre of the slide covering 3 cm X 2 cm

The smear is prepared by using either a wooden stick (Figure 2) or a sterile wire loop (Figure 3).

Steps for Smear Preparation Using a Wooden Stick

• Break the wooden stick into two halves with uneven ends.

• Using the uneven end, select and pick purulent portions of the sputum specimen and transfer onto a new, clean, labelled, glass slide.

• Using the wooden stick, spread the sputum evenly, in a continuous rotational movement, to cover two-thirds of the central portion of the slide. Smear preparation should be done near a flame. This is required as approximately 6 inches around the flame is considered as a sterile zone which coagulates the aerosols raised during smear preparation.
• Discard the used wooden sticks in the discard bucket or a foot-operated bin with a liner and disinfectant. A different broomstick is used for each smear so that one patient's sputum is not mixed with another patient's sputum.

​

• Air-dry the smear slide on the rack for 30 minutes
• After air-drying, heat-fix the smear, using a lighted spirit lamp.

Steps for Smear Preparation Using a Wire Loop

• Take a nichrome wire loop or a disposable loop.

• Using the loop, select and pick purulent portions of the sputum specimen and transfer onto a new, clean, labelled, glass slide.
• Using the loop, spread the sputum evenly, in a continuous rotational movement, to cover two-thirds of the central portion of the slide.

• After use, sterilize the loop in an electric loop sterilizer or flame the loop to red-hot.

​

• Air-dry the smear slide on the rack for 30 minutes.
• After air-drying, heat-fix the smear using a lighted spirit lamp.

Resources

• Module for Laboratory Technicians (RNTCP), Central TB Division, MoHFW, 2005.
• Laboratory Diagnosis of Tuberculosis by Sputum Microscopy, GLI Initiative.

Kindly provide your valuable feedback on the page to the link provided HERE

For sputum smear microscopy, the slides should be air-dried as heating the slide while the smear is wet can result in bubbling of TB bacilli into the air.

Fixation makes the sputum stick to glass slide and preserves the shape of the bacilli. 

The procedure for air-drying and heat-fixing the slide is as follows:

• A smear prepared on a clean glass slide from mucopurulent portion of the specimen is air dried for 15-30 minutes on a rack (see Figure 1)

Figure 1: Rack for air-drying slides

• When dry, the smear facing upwards is fixed by heat from below. This can be achieved by passing the slide 2-3 times over the flame of a spirit lamp (as shown in Figures 2 and 3) for 3-4 seconds each time.

Figure 2: Fixing the Smear by Heat Fixation; Source: Laboratory Diagnosis by Sputum Smear Microscopy

Figure 3: Spirit lamp used to heat-fix smears

Important points to consider when fixing smears

• Heat fixing does not always kill Mycobacteria, exercise care when handling slides.
• Flame fixing may aerosolize bacilli from the smear.
• Overheating can damage the bacilli, burn the smear or break the slide.
• Insufficient heat or time can lead to smear washing off during staining steps.
• Heating for too short a period can result in a false-negative result because the TB bacilli will not be well preserved on the slide.

After the smears are fixed, they can be stained for examination or stored, or used in proficiency testing panel and quality control slides for staining.
 

Resources

Laboratory diagnosis by sputum smear microscopy

Method for Inactivating and Fixing Unstained Smear Preparations of Mycobacterium tuberculosis for Improved Laboratory Safety

Assessment

Good quality smears are essential for accurate examination and results. A good quality sputum smear is one that is of uniform thickness and made from the mucopurulent portion of the sample in the center of the slide (Figure 1).

Do’s and Don’ts of a Good Quality Smear

• Do ensure that the smear size is 3 cm by 2 cm
• Do ensure there are no fingerprints on the prepared smear

Figure 1: Uniform spread of smear, not too thick or thin, and covering an area of 3cm by 2cm

• The smear should not be very thick, but it should be thin enough to visualize a newsprint as can be seen in Figure 2

Figure 2: Smear thin enough to visualise a print through it

• All smears should be air-dried for 30 minutes, before heat fixing to ensure that the smear is not washed off during staining

Common Mistakes to Be Avoided

Resources

• The Handbook - Laboratory Diagnosis of Tuberculosis by Sputum Microscopy, 2013
• Module for Laboratory Technicians – RNTCP, 2005
• Manual for Sputum Smear Fluorescence Microscopy- RNTCP

Kindly provide your valuable feedback on the page to the link provided HERE

The National TB Elimination Program (NTEP) recommends freshly preparing reagents from commercial procured products, at the District TB units to be used for microscopy. Chemicals need to be carefully monitored for potency and the calculation needs to be accurate while preparing reagents for smear microscopy.

For Preparing 1% Carbol Fuchsin (500ml): The required chemicals and materials for preparing 500 ml Carbol Fuchsin are:

1. Basic Fuchsin

• Chemical name: Pararosaniline hydrochloride 
• Chemical structure: C19H18N3Cl
• Molecular Wt: 323.8
• Colour: Metallic green

Potency correction factor: Note down the dye content – this should be available on the container. The dye content should be approximately 85% - 88%. To calculate the required amount of basic fuchsin, divide the actual amount required by the dye content. For example: dye content = 85%, actual amount required = 5gms, required amount of dye = 5/0.85 = 5.88 gms.

2. Ethyl Alcohol: 50 ml (Absolute alcohol, purity must be 98-100%)

3. Carbolic acid crystals (Phenol): 25 gms

• Chemical name: Phenol
• Chemical structure: C6H5OH
• Molecular Wt: 94.11
• Melting point: 40°C+2.5

4. Distilled purified water: 500 ml

Steps for Preparing 1% Carbol Fuchsin (500ml)

1. Add 25 gms of phenolic crystals to a conical flask
2. Add 50ml ethanol
3. Mix well until the crystals completely dissolves. Add 50 ml distilled water if required.
4. Conical flask should be kept in water bath set at 60°C or in a trough containing warm water
5. Weigh required amount of basic fuchsin powder and transfer it into a conical flask
6. Mix well until the crystals dissolve well.
7. Make the total volume to 500ml by adding distilled water
8. Filter using Whattman filter paper and transfer into a bottle
9. Label as 1% Carbol Fuchsin - Primary stain
10. Date of preparation, date of expiry, batch no. and the name of the technician or STLS who has prepared the stain should be clearly mentioned on the bottle.
11. Store it in cool place, away from direct sunlight
12. Any time particles start to form in the Carbol Fuchsin solution, the solution must be filtered again

For Preparing 25% Sulphuric Acid (500ml):

• Chemical structure: H2SO4
• Molecular wt: 98.08
• Purity: 95-97%
• Colour: Clear

1. Measure 375ml distil water into a 1L flask
2. In a glass cylinder, measure 125ml concentrated Sulphuric Acid. Pour it slowly and gently into the conical flask containing distilled water. Note: Always add acid to water. Never add water to acid
3. To dissipate the heat generated, place the flask in a trough of water
4. Mix well
5. Allow to cool
6. Transfer into a bottle
7. Label as 25% Sulphuric Acid - Decolorizing Solution
8. Date of preparation, date of expiry, batch no. and the name of the technician or STLS who has prepared the solution should be clearly mentioned on the bottle.

For preparing 0.1% Methylene Blue (500ml):

• Chemical name: Methylthionine chloride
• Chemical structure: C16H18ClN3S
• Molecular Wt: 319.9

Potency correction factor: Note down the dye content – this should be available on the container. The dye content should be approximately 82%. To calculate the required amount of methylene blue, divide the actual amount by the dye content. For example: dye content = 82%, actual amount required = 0.5gms, required amount of dye = 0.5/0.82 = 0.61 gms.

• Weigh the required amount of Methylene Blue
• Dissolve it in 500ml distilled water
• Transfer into a bottle
• Label as 0.1% Methylene Blue
• Date of preparation, date of expiry, batch no. and the name of the person who prepared the solution should be clearly written on the bottle.

Always perform a quality check of the reagents prepared by using Quality Control Positive and Quality Control Negative. If purity is not available on the reagent bottle, then search the website of the company of which the reagent was procured or ask the company about the certificate mentioning about the purity of reagent

Please watch the video below for more information:

Resources

• Module for Laboratory Technicians (RNTCP), Central TB Division, MoHFW, 2005
• TB Lab Consumables Specifications 2019
• SoP for preparation of Laboratory Reagents - WHO
• Laboratory Diagnosis of Tuberculosis by Sputum Microscopy, GLI Initiative

Kindly provide your valuable feedback on the page to the link provided HERE

Reagent preparation is an important activity and it’s essential to use certified chemicals and reagents. One should always check the potency of the chemicals used and calculate the amount to be weighed accordingly.

The following are the steps for reagent (primary stain and counter stain) preparation for Florescence Microscopy:

0.1% Auramine–O (1 L), the primary stain

• Weigh 1 gm Auramine–O and transfer to conical flask.
• Add 30 gm Phenolic crystals (99.5% purity) and mix well.
• Add 100 ml absolute Ethanol (98-100% purity) and mix well.
• Add 870 ml distilled water to make up final volume of 1 L.
• Filter and transfer to amber bottle.
• Label the bottle as 0.1% Auramine–O.
• Date of preparation, date of expiry, batch no. and name of the Senior TB Lab Supervisor (STLS) who has prepared the stain should be clearly mentioned on the bottle.

1% Acid Alcohol (1 L) to decolorize

• Dissolve 5 gm Sodium chloride in 250 ml distilled water.
• Add 5 ml concentrated hydrochloric acid.
• Mix with 750 ml absolute alcohol.
• Always add acid slowly to alcohol, not vice-versa.
• Store in amber coloured bottle.
• Label the bottle as 1% Acid Alcohol.
• Date of preparation, date of expiry, batch no. and name of the STLS who has prepared the stain should be clearly mentioned on the bottle.

0.5% Potassium Permanganate, KMnO₄ (1 L), the counter stain

• Weigh 5 gm of Potassium permanganate (99.5% purity).
• Transfer to a conical flask.
• Take 1 L of distilled water.
• Add small amounts of distilled water tothe  conical flask containing KMnO₄ and mix well.
• Add the remaining distilled water to make up final volume of 1 L.
• Filter and transfer to a bottle.
• Label the bottle as 0.5% Potassium permanganate.
• Date of preparation, date of expiry, batch no. and name of the STLS who has prepared the stain should be clearly mentioned on the bottle.

Table: Preparation of Different Volumes of Stains for FM Microscopy

Resources

• TB Lab Consumables Specifications, 2019.
• SOP for Preparation of Laboratory Reagents - WHO.

Kindly provide your valuable feedback on the page to the link provided HERE

After air drying and heat-fixing of the smear, it needs to be stained for the identification of MTB during microscopy.

The reagents required for the ZN staining procedure are shown in Figure 1. The steps involved in the staining procedure are shown in Figure 2.

Figure 1: Reagents Required for ZN Staining

Figure 2: Steps involved in ZN staining procedure

For a visual representation of the above-mentioned steps, please click the video below.

Resources

Laboratory Diagnosis by Sputum Smear Microscopy, GLI Initiative

Assessment

Characteristics of a Well-stained Slide

• Staining and appearance of Mycobacterium species in ZN staining.
  • The primary dye - carbol-fuschin stains all cells pink in sputum samples.
  • The bacilli retain the primary pink carbol-fuschin on decolourisation with acid-alcohol.
  • Epithelial, pus and mucous cells in the sputum decolourise on the addition of the acid-alcohol and take up the counterstain dye of methylene blue.
  • Thus, Mycobacterium species appears pink against a background of epithelial, pus and mucous cells that appear blue.
• ZN-stained Mycobacterium species are visible as pink, long, slender rods with granules or V-shaped or in clumps.
• Mycobacterium species should not be stained too dark or pale pink.
  • Possible reasons:
    • Smear thickness is not appropriate
    • Insufficient decolourisation
    • Low acid concentration
    • Carbol-fuchsin dries on smear
    • Primary staining/ decolourisation time not appropriate
    • Expired reagents used
  • Possible solutions:
    • Internal quality control of prepared smears and stains
    • Use a stopwatch to time staining steps.
    • Do not overheat carol-fuchsin.
• The counter-stained cells should not be dark blue.
  • Possible reasons:
    • Smear thickness is not appropriate
    • Excessive counterstaining time
    • Inadequate washing after counterstaining
    • Methylene blue concentration is not appropriate
  • Possible solutions:
    • Internal quality control of prepared smears and stains
    • Use a stopwatch to time staining steps
• There should not be any deposits on stained smears.
  • Possible reasons:
    • Stains not filtered
    • Slides not clean
  • Possible solutions:
    • Internal quality control of prepared stains
    • Filter stains
    • Use clean, fresh, unscratched slides for smear preparation.

Resources

1. Laboratory Diagnosis of Tuberculosis by Sputum Smear Microscopy - The Handbook, GLI, 2013.
2. Module for Laboratory Technicians, RNTCP, CTD, 2005.

Assessment

After air drying and heat-fixing of the smear, it needs to be stained.

Fluorescence microscopy (FM) staining should always be carried out in a designated area. The reagents required for the FM staining procedure are shown in Figure 1. The steps involved in the staining procedure are shown in Figure 2.

Figure 1: Reagents Required for FM Staining

Figure 2: Steps involved in FM staining procedure

For a visual representation of the above-mentioned steps, please click the video below:

Resources

Laboratory Diagnosis by Sputum Smear Microscopy, GLI Initiative

Assessment

Light-emitting Diode Fluorescence Microscopy (LED-FM) utilises the fluorescent dye Auramine-O to stain and detect Mycobacterium species in clinical samples.

Characteristics of a Well-stained Slide

• Auramine-O stained Mycobacterium species are visible as bright yellow/ green long slender rods, slightly curved, with variable lengths, single or in clumps, with uniform staining or granular appearance against a dark background (Figure A).

• Slides stained with Auramine-O should not have too much background fluorescence (Figure B)

      Possible reasons:

  • Smear thickness is not appropriate
  • Insufficient decolourisation
  • Counterstain too weak
  • Auramine-O dries on the smear

  • Auramine-O not filtered

    Possible solutions:

    • Internal quality control of prepared smears and stains
    • Use a stopwatch to time-staining steps
    • Filter Auramine-O before use
    • Add a sufficient quantity of stains to cover the smear

• Slides stained with Auramine-O should not have pale fluorescence (Figure C)

      Possible reasons:

  • Smear thickness is not appropriate
  • Low Auramine-O concentration
  • Excessive decolourisation time

  • Stained smears exposed to daylight

    Possible solutions:

    • Internal quality control of prepared smears and stains
    • Use a stopwatch to time-staining steps
    • Store Auramine-O and stained slides in the dark
    • Read stained slides as early as possible
• Non-fluorescent yellow/ green coloured bacillary shapes should not be considered as Mycobacterium species.

• Slides stained with Auramine-O may contain stained artefacts/ background debris which are not Mycobacterium species.

   

Figure: Slides stained with Auramine-O showing bright yellow/ green slender rods (A); slide with too much background fluorescence (B); slide with pale fluorescence (C); Source: Laboratory Diagnosis by Sputum Smear Microscopy

Resources

1. Laboratory Diagnosis of Tuberculosis by Sputum Smear Microscopy - The Handbook, GLI, 2013.
2. Manual for Sputum Smear Fluorescence Microscopy, RNTCP, CTD.

Assessment

The manner and quality of smear reading has a major impact on the result of sputum smear microscopy and case detection. Each slide needs to be examined for at least 5 full minutes or 100 fields need to be examined. 

The overall process of reading a smear is outlined in the figure below:

Figure: Process of reading a smear

Resources:

• AFB Smear Microscopy, Trainer Notes.
• Module for Laboratory Technicians.
• Laboratory Diagnosis of Tuberculosis by Sputum Microscopy.

Assessment

The following are the measures to be kept in mind when adding immersion oil to the slide:

• Before adding immersion oil to the slide, ensure that the smear is facing upwards (Figure 1).

Figure 1: Slide should Face Upwards when Mounted on the Microscope Stage

• Add a drop of immersion oil, using the applicator (dropper bottle).
• The drop must fall freely onto the smear, so that the oil applicator does not touch the slide and get contaminated (Figure 2).

Figure 2: Oil Dropped onto Slide with an Applicator

• Mount the slide on the microscope and use the 10X objective lens to focus the smear, scan and look for mucoid material.
• Carefully rotate the 100X objective lens over the slide, adjust, sharp focus and observe under immersion oil.

Do’s and Don’ts:

• The 100X objective is the only lens requiring immersion oil.
• Keep the immersion oil away from other lenses.
• Use a good quality immersion oil.
• The immersion oil must have a medium viscosity and a refractive index (RI) greater than 1.5.
• Never allow the oil applicator to touch the slide.
• Do not use cedar wood oil diluted with xylene as it leaves a sticky residue on the lens and destroys the lens over time. 

Resources

• Guidelines for Laboratory Consumables, Central TB Division, 2019.
• Laboratory Diagnosis of Tuberculosis by Sputum Microscopy, GLI Initiative.

Kindly provide your valuable feedback on the page to the link provided HERE

Image

Resources

• AFB Microscopy Trainer Notes
• Module for Laboratory Technicians
• Laboratory diagnosis by sputum smear microscopy

Kindly provide your valuable feedback on the page to the link provided HERE

Smears stained with the fluorescent dye, Auramine, are read with a Light Emitting Diode Fluorescence Microscope (LED-FM).

• The fluorescent-stained smears are to be read within 24 hours of staining in a dark room as the fluorescent stain fades on exposure to light.
• The slides are to be stored in the slide box to avoid exposure to light. Alternatively, they may be stored wrapped in brown or black paper and kept away from light.
• The slides should not be stored in a fridge as 4°C does not prevent or delay fading of fluorescent dye.

After fluorescent staining, smears are examined at much lower magnifications (typically 200x) than used for Ziehl Neelsen (ZN)-stained smears (1000x). Each field examined under fluorescence microscopy, therefore, has a larger area than that seen with bright field microscopy.

Examination Procedure

The steps include:

1. Switch on the LED-FM in a dark room.

2. Focus the stained slide using a 20x or 40x objective lens and view through the 10x eyepiece (magnification of 200x or 400x).

- Does not require the use of oil immersion.

3. Read smear in a linear pattern.

4. Count bacilli that appear as slender bright yellow fluorescent rods against a dark background in 30-50 fields. Rule out any artefact.

- For a trained and experienced Lab Technician (LT), each smear would take approximately 2 minutes for 30-50 fields or three horizontal sweeps.

Reporting Procedure

The smears are reported as negative/ scanty/ 1+/ 2+/ 3+ per the grading scale (Table).

Table: A Comparison between ZN (1000x) and FM (400x and 200x) for Grading of Smears at Different Magnifications

Abbr: AFB: Acid Fast Bacilli; HPF: High Power Field

Resources

• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.
• Manual for Sputum Smear Fluorescence Microscopy, RNTCP, MoHFW, 2007.
• Fading of Auramine-stained Mycobacterial Smears and Implications for External Quality Assurance.

Assessment

Each Designated Microscopic Center (DMC) needs to maintain a National TB Elimination Program TB (NTEP) Laboratory Register which collects information of all presumptive TB patients who undergo tests or confirmed patients who undergo follow-up tests.

• After doing the Acid-fast Bacilli (AFB) test, the laboratory technician needs to ensure that all the microscopy test results are entered against the name and the serial number of the presumptive/ confirmed TB patients.
• The result needs to be mentioned in terms of positive or negative test results along with the AFB grading.
• It is expected that the positive results are written in RED and negative in BLUE point pens.
• The AFB results can be mentioned for newly diagnosed TB patients for both spot as well as morning sample and must include the Nikshay ID of the patient as well as the test date and result.
• In case, the sample is repeated, the same is also mentioned.
• All the information also needs to be entered into NTEP Nikshay online application using a tablet or mobile phone.
• In a setting where Nucleic Acid Amplification Test (NAAT) is co-located, another sample needs to be tested for Rifampicin (Rif)-resistance and the same result also needs to be noted into the TB laboratory register.
• The performance of each laboratory is also entered into the monthly DMC extract called Annexure M which is consolidated for all DMCs by the concerned Senior TB Laboratory Supervisor (STLS).
• HIV and diabetes tests are also offered to each confirmed TB case and the details of the same are also part of the TB laboratory register.
• Patients who have been tested also need to be provided with the test results in a hard copy apart from the provision of information to the treating clinician of the health facility.

Resources

• RNTCP Module for Laboratory Technician, CTD, MoHFW, 2005.

Kindly provide your valuable feedback on the page to the link provided HERE

Results of Ziehl–Neelsen (ZN) and Fluorescence Microscopy (FM) are added to Nikshay Diagnostic Module. After a patient is registered, test details are added which then leads to the page to add details on sample type, facility and test results (Figures 1-6).

Features of Nikshay Diagnostic Module

• A simplified user workflow for adding and updating test requests and results.
• Tests can be added and all the added tests’ history is available.
• Ability to map samples to one or more tests within Nikshay.
• A “Workbench” view is available to provide a single interface to view/ print/ copy the Test Summary, Add/ View Sample Details and Update/ View Result details.

Figure 1: Nikshay Screenshot to Add Tests under Diagnostics Module.

To add results for ZN/FM, the test types either Microscopy ZN or Microscopy Fluorescence should be selected from the drop-down menu (Figure 2).

Figure 2: Nikshay Screenshot to Add Reasons for Test under Diagnostics Module.

In case of follow-up with ZN/FM Microscopy, the reason for follow-up should be selected (Figure 3).

Figure 3: Nikshay Screenshot to add Follow-up ZN/FM Microscopy Test under Diagnostics Module.

Figure 4: Nikshay Screenshot to add Test Type for ZN/FM Microscopy and Facility Details under Diagnostics Module.

Details on sample type and sample description (mucopurulent/ blood-stained/ saliva) are added (Figure 5).

Figure 5: Nikshay Screenshot to add Sample Details and Description for ZN/FM Microscopy under Diagnostics Module.

Under test results, as shown in Figure 6, details of lab serial number, sample number, test date, test reported date and final interpretation of results are added based on the selection from a drop-down menu that includes options for:

• Negative
• Positive (1+, 2+, 3+)
• Positive (Scanty 1-9)

Figure 6: Nikshay Screenshot to add Test Results for ZN/FM Microscopy under Diagnostics Module.

Resources

• Nikshay Zendesk, Nikshay Knowledge Base, Diagnostics.

Assessment

The DMC lab register can be generated from Nikshay as a spreadsheet and stored electronically or printed for paper records.

Steps for generating DMC Register from Nikshay:  

1. Login to Nikshay Reports using your login ID and password.
2. Under Reports, click on ‘Patient wise List’ and select the option for ‘DMC Register’ (see screenshot below) 

Figure: Screenshot of Nikshay Reports to generate DMC Register 

A few filters need to be selected to generate the register.  

1. First is the geographic location (State/ District/ TU/PHI); most of these are preselected.
2. This is followed by a selection of the period for which the register has to be generated. This includes selection of ‘Frequency’ (either monthly or annually)of the report and the month or quarter for which the report is required. 
3. Click on the ‘Generate Excel’ button and it will lead you to a page from which you can download the register. 

Things to remember:

• You can generate a DMC register for facilities below your login level (e.g., a district can generate a DMC register of a TB Unit or DMC of the same district. and a State can generate a register for any District under it) 
• The data included in the register is based on the "Date reported" of a test.

Video: Steps to access the DMC Register in Ni-kshay

Resource 

Nikshay Reports Module 10 

Assessment 

The CBNAAT module contains components that enable automated sample processing in the cartridge, and filling of the tube with the sample-reagent mixture for Polymerase Chain Reaction (PCR), followed by PCR amplification and detection.

The structure of the CBNAAT module is described below and shown in Figure 1:

• Syringe pump drive or plunger motor: Dispenses fluids into the different cartridge chambers
• I-CORE module: Performs PCR amplification and detection
• A cartridge loading and unloading mechanism ensures the proper movement of the cartridge in the instrument
• Reaction/PCR tube: Enables rapid thermal cycling and optical excitation and detection of the tube contents. The reaction tube is automatically inserted into the I-CORE module (hardware for PCR amplification and fluorescence detection) when the cartridge is loaded into the instrument.
• Valve drive: Rotates the cartridge valves to align the chambers with the syringe
• Ultrasonic horn: Lyses the sample

Figure 1: Structure of the CBNAAT module

The interior region of the cartridge insertion site also called cartridge bay and is shown in Figure 2.

Figure 2: Interior of the Cartridge Bay

Mode of Operation of the CBNAAT Module 

• The Intelligent Cooling/Heating Optical Reaction (I-CORE) module is the hardware component, within each instrument module, that performs PCR amplification and, fluorescence detection.
• As part of the cartridge load process, the PCR tube is inserted into the ICORE module. 
• As the test starts, the sample and reagent mixture are pushed from the cartridge, into the PCR tube.
• During the amplification process, the ICORE heater heats up and the fan cools down the reaction tube contents.

Within the I-CORE, there is an optical system composed of two blocks: A six colour excitor and detector block excite the dye molecules, and detect the fluorescence emitted.

Figure 3: Mode of operation of the CBNAAT module

Resources

• Training material Cepheid Hbdc 3a GeneXpert technology

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The disposable, single-use CBNAAT cartridge is a closed system unit to hold the samples and reagents. Inside of a CBNAAT Cartridge (CBNAAT operator manual). Each cartridge consists of the following components:

• Processing chambers: Hold samples, reagents, processed samples, and waste solutions. One chamber is designated as an air chamber to equilibrate pressures within the cartridge.
• Valve body: Rotates and allows fluid to move to different cartridge chambers and to the reaction tube. Within the valve body, the specimen is isolated, PCR inhibitors are removed, and the sample is mixed with PCR reagents and moved into the integrated reaction tube.
• Reaction tube: Enables rapid thermal cycling and optical excitation and detection of the tube contents. The reaction tube is automatically inserted into the I-CORE module (hardware for PCR amplification and fluorescence detection) when the cartridge is loaded into the instrument.

Resources

• CBNAAT operator manual

The consumables required at a Cartridge-based Nucleic Acid Amplification Testing (CBNAAT) laboratory include the following:

CBNAAT/ GeneXpert Dx System consisting of CBNAAT machine preloaded with assay software, Computer and the Barcode reader

• CBNAAT assay kit (Figure) consisting of:
  • CBNAAT cartridges: Kit contains 10 or 50 individually packed cartridges.
  • CBNAAT reagent: 8 ml volume pack per cartridge. The sample reagent solution is clear but may range from colourless to golden yellow.
  • Sterile pipette: Individually packed, disposable transfer pipettes, one per each test, with a single mark for the minimum volume of sample transfer to each cartridge.
  • CD containing the Assay Definition File.

Figure: Contents of CBNAAT Assay Kit; Source: GLI Training Package for CBNAAT.

• Sputum containers 

• Personal protective equipment:
  • Laboratory coats
  • Disposable gloves
     
• Disinfectants
  • 1% Sodium hypochlorite solution 
  • 5% Phenol
  • 70% Ethanol 
     

• Power stabiliser (UPS) for uninterrupted power supply to perform CBNAAT assay.

   

Resources

• GLI Training Package for CBNAAT.  
• FIND Diagnosis for All, CBNAAT SOP.

Assessment

Cartridge-based Nucleic Acid Amplification Test (CBNAAT) is used to detect Mycobacteria tuberculosis and rifampicin-resistance using GeneXpert IV Dx system and the Xpert MTB/ RIF cartridge.

The CBNAAT system integrates and automates sample processing, nucleic acid amplification, and detection of Mycobacteria tuberculosis and rifampicin resistance.

The system utilises the use of single-use disposable CBNAAT cartridges that hold the Polymerase Chain Reaction (PCR) reagents and hosts the PCR process.

The process involves the following steps:

1. Sample processing: Specimens are processed by adding the sample reagent at 2:1 (v/v) ratio to the sputum sample, mixing and incubation for 15 minutes at room temperature. The sputum sample get liquified after the processing step.
2. Loading sample into cartridge: Liquefied sample is added to the cartridge using a transfer pipette.
3. Setting up the machine to run the test: After switching on the system, “Create Test” (Figure A) is clicked in the GeneXpert Dx system window, test details are added, the barcode label of the cartridge is scanned (Figure B) and “Start Test” (Figure C) is clicked to initiate testing.

Figure: Setting the machine to run the assay by creating test (A), adding test details, scanning barcode (B) to start test (C); Source: GLI Training Package for CBNAAT.

4. Loading the cartridge: The instrument module door which displays the blinking green light is opened to load the cartridge. The door of module is closed firmly (an audible click sound should be heard). The green light stops blinking when the test starts.
5. Obtaining the results: When the test is finished, the green light turns off. It takes around 1 hour 55 minutes to complete test run. On completion of test run, the result is generated automatically on the monitor.
6. Ending the test run: When the system releases the door lock at the end of run, the module door is opened to remove the cartridge. The used cartridge is discarded.

Resources

• GLI Training Package for CBNAAT.  
• FIND Diadnosis for All, CBNAAT SOP.

Assessment

Introduction

Cartridge-based Nucleic Acid Amplification Test (CBNAAT) is an automated rapid molecular diagnostic test which detects targeted Deoxyribonucleic Acids (DNA) sequences of Mycobacterium tuberculosis (M.tb) genome by Real-time Polymerase Chain Reaction (RT-PCR) method.

CBNAAT uses the GeneXpert IV Dx system and the single-use disposable Xpert M.tb/ Rifampicin (RIF) cartridges that hold the Polymerase Chain Reaction (PCR) reagents and host the PCR process.

The various TB tests utilizing the CBNAAT platform:

1) GeneXpert MTB/ RIF

• The Xpert M.tb/ RIF assay is a Nucleic Acid Amplification Test (NAAT) that uses a disposable cartridge with the GeneXpert Instrument System to quickly identify possible Multidrug-resistant TB (MDR-TB) that is resistant to RIF.
• This test yields rapid results, i.e., within 2 hours and is therefore cost and time-saving.

2) GeneXpert MTB/ RIF Ultra 

• The Xpert M.tb/ RIF Ultra assay is similar to the Xpert MTB/ RIF assay, just that it is even faster with a higher level of accuracy.
• The results are obtained in 80 minutes.
• It can detect paucibacillary TB disease.

3) GeneXpert MTB/ XDR

• This is a GeneXpert M.tb assay that detects mutations associated with Resistance Towards Isoniazid (INH), Fluoroquinolones (FLQ), Second Line Injectable Drug (SLID) (amikacin, kanamycin, capreomycin) and Ethionamide (ETH) in a single test.

4) GeneXpert Omni/Edge

• GeneXpert Omni/Edge is a battery-operated, wireless and web-enabled portable molecular diagnostics system, intended for use as the point-of-care diagnostic tool in remote and challenging settings.
• It is a single-slot platform i.e., runs one test per cycle, uses a 2-in-1 tablet/laptop and a compact printer and is expected to enable accurate, fast and cost effective test results.

Apart from TB, the CBNAAT platform can be used to diagnose several other pathogens using different cartridges. One of the common other pathogens detected using CBNAAT in India is COVID-19.

Note: Except GeneXpert MTB/ RIF , other CBNAAT tests are not currently being endorsed by NTEP.

Resources

• WHO Consolidated Guidelines on Tuberculosis. Module 3: Diagnosis - Rapid Diagnostics for Tuberculosis Detection 2021 Update.
• Guidelines for Programmatic Management of Drug-resistant TB (PMDT) in India; NTEP, CTD, MoHFW, India, 2021.
• Sachdeva K, Shrivastava T. CBNAAT: A Boon for Early Diagnosis of Tuberculosis-Head and Neck; Indian J Otolaryngol Head Neck Surg, 2018.

Assessment

The CBNAAT System automatically performs internal quality control for each sample. 

During each test, the system uses the following inbuilt controls:

System Check Control (SCC)

• Checks integrity of the instrument, cartridges and PCR reagents.

Sample Processing Control (SPC)

• Ensures that a sample is correctly processed.
• Included in the cartridge and is processed with the sample. The DNA is detected by a PCR assay.

Probe Check Control (PCC)

• Performed during the first stage of the test.
• Verifies the presence and integrity of the labelled probes.

Video 1: CBNAAT Technology -Inbuilt Controls

Video 2: Summary of all In-built Control Checks

Resources

• CBNAAT Operator Manual.