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Indian Council of Medical Research (ICMR) Issues Protocol for Evaluating TB Detection Technologies: A Generic Concordance Study

NextEdge Admin

16 May 2024

2 min 55 sec

The Indian Council of Medical Research (ICMR) has issued a Generic Concordance Study Protocol aimed at evaluating tuberculosis (TB) detection technologies. This protocol seeks to establish the agreement between two iterations of an approved molecular TB detection technology. Through a cross-sectional approach, it aims to ascertain the concordance in identifying both TB and drug-resistant TB cases.

The primary objective of this protocol is to compare the performance of a previously validated TB detection platform with a newer version. The study will assess true agreement in detecting TB and drug resistance, utilizing reference tests like Xpert MTB or Line Probe Assay (LPA) for comparison. By evaluating sensitivity and specificity, the protocol aims to determine if the newer version is equivalent in performance to the established platform.

Diagnosing adult pulmonary tuberculosis and drug-resistant TB remains a significant challenge in endemic regions, impeding global TB elimination efforts. Traditional culture-based methods and drug susceptibility tests demand high biosafety standards, often limiting their accessibility to specialized laboratories.

Nucleic acid amplification tests (NAATs) have shown promise due to their heightened sensitivity and specificity in detecting Mycobacterium tuberculosis. While the Xpert MTB/RIF assay and Truenat MTB-RIF Dx have been approved and implemented by the National Tuberculosis Elimination Programme, they are restricted to rifampicin resistance detection. Recent advancements have introduced closed systems capable of simultaneously detecting M. tuberculosis complex and resistance to rifampicin and isoniazid.

The landscape of TB diagnostics is rapidly evolving, with manufacturers developing improved versions of approved technologies to suit various settings. To integrate these modifications effectively, it is crucial to conduct concordance studies to ensure that newer iterations maintain performance equivalence with established platforms. This protocol provides a structured framework for evaluating the performance of modified TB detection technologies, facilitating their adoption in TB control programs worldwide.