Base Technical Content in text and simple images.
The MGIT tube contains a modified Middlebrook 7H9 broth base, which contains large amounts of dissolved oxygen (Figure below). The headspace of the tube is flushed with a carbon dioxide enriched atmosphere.
Components of MGIT Medium Tube
MGIT 960 reagents include (Figure):
Figure: BACTEC MGIT 960 Reagents
Storage of Reagents
Monitoring of key quality indicators or performance indicators of Truenat is important to assess the functioning of the instrument, calibration/ service requirements of the instrument, competency of the technician performing the assays and inventory management. Overall quality indicators should assess:
Need-based maintenance for Truenat instrument is done by lab personnel/ manufacturer while the manufacturer does annual maintenance.
The tasks included under annual maintenance are:
The Truenat Assay Technology works on Real-time Polymerase Chain Reaction (PCR).
The key steps include:
External Quality Assurance (EQA) ensures that high-quality testing can be carried out efficiently and without interruption. It involves Proficiency Testing (PT) and On-site Evaluation (OSE).
PT is an important component of EQA for Cartridge-based Nucleic Acid Test (CBNAAT) under the National TB Elimination Program (NTEP) and guarantees accurate and reproducible results.
Importance of EQA/ PT for CBNAAT
Under the National TB Elimination Program (NTEP), each Cartridge-based Nucleic Acid Test (CBNAAT) site needs to keep a maintenance record for the instrument.
Cleaning and disinfecting the system components is crucial for proper CBNAAT maintenance. The tasks and frequency are shown in the table below.
On completion of a test run, the Cartridge-based Nucleic Acid Amplification Test (CBNAAT) gives the following results:
Conclusive results include: MTB NOT DETECTED, MTB DETECTED with Rif Resistance/ without Rif Resistance.
Adverse Drug Reaction (ADR): An unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs, under normal conditions of use, and is suspected to be related to the drug.
Adverse Event (AE): Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease that presents in a patient during the course of treatment or the procedure, regardless of whether it is considered related to the medical treatment or procedure.
Active Drug Safety Monitoring (aDSM) is a proactive effort made to elicit adverse events from patients by directly asking the patient, screening records, and checking laboratory and clinical tests. All adverse events are captured systematically at all patient visits (during treatment initiation, treatment review and extra visits).