The government’s ban on serological tests for tuberculosis follows a WHO recommendation to ban inaccurate and unapproved blood tests a year ago
Last week, the Union Ministry of Health and Family Welfare banned a multi-million dollar business centred on selling substandard tests on tuberculosis with unreliable results, roundly railed against by the World Health Organisation a year ago. A subsequent notification called for a halt to the import of the serological test kits, commonly known as blood or antibody tests for TB.
In July last year, the Geneva-based WHO in a policy recommendation urged countries to ban the inaccurate and unapproved blood tests and instead rely on accurate microbiological or molecular tests. The call stems from the realisation that testing for active TB disease through antibodies or antigens found in the blood is intractable. Patients can have different antibody responses suggesting that they have active TB even when they do not. Antibodies might also develop against other organisms which again could erroneously show up as active TB. Besides, different organisms share the same antigens, rendering tests results undependable.
WHO reckoned that more than a million of these inaccurate blood tests are carried out annually to diagnose active TB, often at substantial financial cost to patients the world over with many patients paying up to 30 dollars per test. Most of these tests, at least 18 such tests available in the market, are manufactured in Europe and North America, which are seldom approved by any recognised regulatory body. Coordinator of TB Diagnostics and Laboratory Strengthening for the WHO Stop TB Department Dr Karin Meyer contended that “blood tests for TB are often targeted at countries with weak regulatory mechanisms for diagnostics, where questionable marketing incentives can override the welfare of patients”.
Ardent health activists, citing a monograph in the National Medical Journal of India, said as many as 1.5 million TB serological tests are estimated to be done in the country with patients paying an estimated Rs 75 crore per year on these tests of questionable quality. This is despite the fact that the Revised National TB Control Programme (RNTCP) has never recommended these tests and guidelines such as the International Standards for TB care and those by the Indian Academy of Paediatrics dissuaded the practice widely purveyed by the private sector on gullible patients.
Data by research bodies from civil societies reveal that TB is the single largest infectious disease in the world with India witnessing an estimated two million new cases a year and 1000 deaths a day. TB spreads through the air and when a person with TB coughs, sneezes or spits in public places, he sprays droplets containing TB bacteria and people in the contiguous area breathing that risk becoming infected.
This is compounded by the cramped and unventilated shovels in poor urban settlements, such as slums where the urban poor are vulnerable to infection. Unless a sustained campaign against such scurvy practice as spitting in public and decongesting the urban habitations is made by the authorities, supplemented by private and civic initiatives, the problem would only worsen.
Just as anti-polio campaigns with celebrities succeeded in bringing awareness of the problem, citizens feel, the authorities should think of roping in personalities from the tinsel world or corporate houses in a minimalist programme to mount a campaign to bring about basic awareness and perception of TB among the public.
Dire paucity of best practices, supervision, coordination and regulation within the private sector portend immense adverse implications for public heath, particularly in the light of an unregulated private sector comprising practitioners, pharmacists and diagnostic labs. It is felt, banning of more such sterile and expensive tests should follow if public health practices and policies are to benefit millions of people in India.