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ICMR Releases Protocol for Assessing TB Detection Technologies

Written by : Aishwarya Sarthe

May 16, 2024

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The protocol serves as a benchmark for assessing the accuracy and reliability of various TB diagnostic tools.

In a bid to enhance tuberculosis (TB) detection efforts, the Indian Council of Medical Research (ICMR) has introduced a Generic Concordance Study Protocol to evaluate TB detection technologies. 

The protocol serves as a benchmark for assessing the accuracy and reliability of various TB diagnostic tools. It further seeks to determine the level of agreement between different versions of approved TB detection technologies. 

By comparing the performance of previously validated platforms with newer versions, the study aims to establish concordance in detecting both Mycobacterium tuberculosis (MTB) and drug-resistant TB.

According to an official statement from the ICMR, "This protocol will serve as a guide for evaluating the performance equivalence of the two versions, thus ensuring the reliability and accuracy of TB diagnostic tests."

Addressing Diagnostic Challenges

Accurate diagnosis of adult pulmonary tuberculosis (PTB) and drug-resistant TB remains a significant challenge in many countries, particularly those with high TB burdens. 

Conventional culture-based methods and drug susceptibility tests (DST) often need to be improved in terms of availability and biosafety requirements.

An expert in the field highlighted, "Nucleic acid amplification tests (NAATs) have demonstrated potential due to their superior sensitivity and specificity in detecting MTB. Nevertheless, the emergence of newer versions and platforms demands thorough evaluation to ascertain their efficacy in TB diagnosis."

ICMR’s Recent Initiatives

In tandem with this initiative, the ICMR planned to expand its Indian Clinical Trial and Education Network (INTENT). With 47 participating institutes nationwide, this network is a collaborative platform for conducting clinical trials focused on critical health issues.

The expansion of the INTENT network aims to broaden participation and bolster capacity in conducting scientifically sound clinical trials, explained an ICMR spokesperson. 

By inviting both public and private medical research institutes to join, we aim to address a wider spectrum of health priorities.

Furthermore, in a collaborative effort involving the Central Drugs Standard Control Organization (CDSCO) and MedTech Mitra, the ICMR aims to elevate standards in In Vitro Diagnostics (IVDs) across India. 

This strategic partnership aims to tackle inherent challenges within the diagnostic sector and establish a robust testing and validation framework.

Also, in a recent development, the Indian Council of Medical Research conducted a trial run under its i-Drone initiative. Under this initiative, the research body transported tissue samples for cancer diagnosis surgery.

Taking such initiatives implies ICMR’s aim to expand the drone ecosystem in India, particularly in the healthcare sector, to enhance accessibility and efficiency.

Further, in another recent trial run, a tissue sample was transported in the midst of surgery from Dr TMA Pai Hospital, Karkala, to Kasturba Medical College, Manipal Academy of Higher Education Manipal, covering a distance of approximately 37 km.


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