Trends in the TB diagnostic markets in India have been changing drastically. Serological TB tests have been very popular in the Indian private market for the past several years, despite the fact that these are known to be inaccurate, inconsistent and of no clinical value for TB diagnosis.

Also read:

• Life after TB diagnostic ban in India?
• Indian Experts slam serological TB tests

Related interviews / columns:

• Dr Gyanu Lamichhane - Johns Hopkins Center for Tuberculosis Research
• Dr Niraj Shende - TB diagnosis needs effective regulatory approach
• Dr Lucica Ditiu, executive secretary, Stop TB Partnership
• Mr Mohit Malhotra - MD and head of country operations, Sandoz India
• Dr Koen Andries - distinguished research fellow, Tibotec 
• Dr Peter Small - senior program officer for TB, Bill and Melinda Gates Foundation
• Dr Mel Spigelman - director, R&D, TB Alliance
• Dr Nalin Mehta - senior communications manager, The Global Fund, and joint editor, SAHC

According to a paper published in the National Medical Journal of India, "Despite the evidence and lack of any supporting policies, 1.5 million TB serological tests are estimated to be done in India and as a result, patients end up spending an estimated $15 million (Rs80 crore) per year." In fact, another market research survey has estimated that, more than $40 million (Rs200 crore) are spent on TB serology in India annually.

In the editorial of the Indian Journal of Medical Research, published in November 2011, Professor Sarman Singh, head, division of clinical microbiology and molecular medicine, All India Institute of Medical Sciences (AIIMS), and Dr VM Katoch, director general, Indian Council for Medical Research (ICMR), discard the claims of manufacturers as misguiding. They point out that there are more than 73 manufacturers of TB serological test kits. There are at least 24 TB rapid test kit manufacturers from China alone, followed by the US. India has eight rapid test manufacturers. Most of them claim 95-to-100 percent sensitivity and specificity.