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  • Laboratory Hierarchy and Network

    Content

    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

     

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  • National Reference Laboratories [NRL]

    Content

    The National Reference Laboratories (NRLs) constitute the third tier of the National Tuberculosis Elimination Programme (NTEP) laboratory network hierarchy. 

     

    They provide quality assurance and certification services for the Culture and Drug Susceptibility Testing (C&DST) labs and coordinate with the World Health Organisation (WHO) Supranational Reference Laboratory (SNRL) network.

     

    There are six designated NRLs which are delineated in the figure below.

    NRL

    Figure: Six National Reference Laboratories under NTEP in India

    NIRT, Chennai, in addition to being one of the NRLs is also one of the WHO designated SNRLs for the Southeast Asia Region.

     

    Resources

     

    Question 

    Answer 1 

    Answer 2 

    Answer3 

    Answer 4 

    Correct Answer 

    Correct explanation 

    Part of pre-test

    Part of post-test

    How many designated NRLs are there in India?​

    8

    6

    4

    2

    2

    There are 6 designated NRLs in India.

    Yes

     

    Yes

    Who is responsible for quality assurance and certification services for the C&DST labs?

    IRLs

    State TB Cell

    NRLs

    Central TB Division

    3

    NRLs provide quality assurance and certification services for the Culture and Drug Susceptibility Testing (C&DST) labs and coordinate with the World Health Organisation (WHO) Supranational Reference Laboratory (SNRL) network.

    Yes

     

    Yes

     

  • Intermediate Reference Laboratories [IRL] and their role

    Content

    Some Culture and Drug Susceptibility Test (C&DST) laboratories host an Intermediate Reference Laboratory (IRL) under the National TB Elimination Programme (NTEP). 

    There is at least one IRL per state at an identified location, usually in a secondary or tertiary level public health facility. There are 34 IRLs in India.

    The IRLs are 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

     

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  • CDST labs and their role

    Content

    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)

     

     

     

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  • NAAT Labs and their role

    Content

    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.)

     

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  • Functions of a Designated Microscopy Centres [DMC]

    Content

    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. 

     

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  • Sputum Collection centres

    Content

    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

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    Assessment:

    Question Answer 1 Answer 2 Answer 3 Answer 4 Correct answer Correct explanation Page id Part of Pre-test Part of Post-test
    Under NTEP, where are sputum collection centres established to increase access to diagnostic services?  Tribal areas Ayushman Bharat health and wellness centres Difficult-to-reach areas All of the above 4 To increase access to diagnostic services, sputum collection centres are established in Ayushman Bharat health and wellness centres, Urban health centres, tribal, hilly, desert and difficult-to-reach areas of the country.   Yes Yes