Almost a year after the World Health Organisation (WHO) issued a rare ‘negative’ policy recommendation urging countries to ban the use of serological (blood) test kits for active TB, the Ministry of Health & Family Welfare, Government of India has issued a notification prohibiting the manufacture, sale, distribution, use and import of such serodiagnostic kits.
India as a country has one fifth of the global TB burden, with some estimates putting a total of 9.2 million new cases and 1.7 million deaths every year.
In a notification dated June 7, the Central Government states that “it is satisfied that the use of the serodiagnostic test kits for diagnosis of tuberculosis are giving inconsistent and imprecise results results leading to wrong diagnosis and their use is likely to involve risk to human beings and whereas safer alternatives are available.”
WHO’s recommendation in July last year came after a year of rigorous analysis of evidence by WHO and global experts. Ninety-four studies were evaluated—67 for pulmonary tuberculosis (TB in the lungs) and 27 for extrapulmonary tuberculosis (TB elsewhere in other organs). Overwhelming evidence showed that the blood tests produced an unacceptable level of wrong results—false-positives or false-negatives—relative to tests endorsed by WHO.
The impact of false-negatives would be that a person needing TB treatment would not get it, and the disease would progress, with tragic consequences. The impact of false-positives in a disease like TB, which has a social stigma attached to it is also significant. Besides the stigma, such cases could also suffer from the side effects of anti-TB medication, which is actually not required. In both cases, it would mean a waste of financial resources.
Industry observers active in the field of TB diagnostics research say that the June 7 notification is a big step as India is probably the first and only country to have banned these tests, following the WHO policy.
If the ban is properly enforced, the hope is that patients in the private sector will be protected from a test that confuses and misleads the patient.
The WHO guidelines are already endorsed by the TB Division of the Government of India but as this division had no control over the import of these tests, they were still available in the Indian market and in use. Hence, the GoI notification of June 7 is significant.
EP News Bureau – Mumbai
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