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ICMR releases Generic Concordance Study Protocol for assessing TB detection technologies

Shardul Nautiyal, Mumbai
Wednesday, May 15, 2024, 08:00 Hrs  [IST]

The Indian Council of Medical Research (ICMR) has released Generic Concordance Study Protocol for assessing TB detection technologies.

This is a generic protocol to determine the true agreement between two versions of an approved technology for the molecular detection of tuberculosis and drug-resistant tuberculosis.

The objective of the protocol is to establish concordance between the previously validated platform and the new version. The study will follow a cross-sectional design, aiming to determine true agreement in confirmed positives and negatives for both MTB and MDR-TB.

The objectives include assessing true agreement in detecting MTB and drug resistance, comparing sensitivity and specificity with reference tests like Xpert MTB or Line Probe Assay (LPA). This protocol will serve as a guide for evaluating the performance equivalence of the two versions.

Accurately diagnosing adult pulmonary tuberculosis (PTB) and drug-resistant TB remains a major challenge in endemic countries, hindering the achievement of the TB elimination goal. The priority in high-burden countries has been to develop reliable, rapid, and affordable TB tests.

Conventional culture-based identification and drug susceptibility tests (DST) require highest biosafety measures in TB laboratories, often limiting their availability to national or higher-level regional laboratories.

Nucleic acid amplification tests (NAATs) for mycobacterium tuberculosis (MTB), specifically amplifying distinct nucleic acid regions, have exhibited promise due to their high sensitivity and specificity.

Currently, the National Tuberculosis Elimination Programme MTB/RIF assay and Truenat MTB-RIF Dx, (NTEP) has approved and introduced the Xpert.

However, these tests are limited to both capable of detecting rifampicin resistance detection only. Recent advancements include development of nucleic acid amplification techniques based closed systems with simultaneous detection of Mycobacterium tuberculosis complex, TM MTB/RIF-INH resistance to rifampicin (RIF) and isoniazid (INH).

TB diagnostics is expanding exponentially where different and improved versions of an approved technology have been developed by the manufacturers to accommodate different settings.

In order to utilize these modified versions or platforms of the same approved technology, a concordance study is required to demonstrate whether the newer version for molecular detection of tuberculosis and drug resistant tuberculosis can achieve equivalent performance to the existing version or platform.


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