Move comes a year after WHO said the test leads to misdiagnosis
The Union health ministry has banned blood tests to detect tuberculosis while terming these tests useless. The ban came into effect on June 7, almost a year after the World Health Organization (WHO) issued an advisory to countries to stop conducting these tests for TB. The international body said in July 2011 that these tests give inaccurate results and can lead to misdiagnosis.
In a notification issued by the ministry, joint secretary Arun K Panda writes: “The central government is satisfied that the serodiagnostic test kits for diagnosis of TB are giving inconsistent and imprecise results, leading to wrong diagnosis.” He adds that the use of these kits are likely to pose a risk to humans and the government has banned the manufacture, sale, distribution and use of these test kits in “public interest”. The kits have been banned under the Drugs and Cosmetics Act of 1940.
Civil society groups working on TB commend this move by the government and say it will benefit patients who spend money on these expensive tests that are inconclusive. “This is a positive move. These expensive tests are not specific tests to diagnose TB and they just make the poor poorer. The correct diagnosis of the disease is also delayed, leading to complication of the disease,” said Blessina Kumar, vice-chairperson of Stop TB partnership, an alliance of non-profits working with TB patients.
Costly and inaccurate
The blood test for TB costs between Rs 800 and Rs 1,000. It gives the result in two days. No government hospital or health care centre uses this test to diagnose TB. This test is only available in the private hospitals. The government hospitals base the TB diagnosis on the sputum test. There are other cheap alternatives available to diagnose TB, like the tuberculin test, also called the skin test, that costs only Rs 25 if done privately. In the government hospitals, this test is free.
“The blood test for TB is a redundant test. It doesn't give accurate results. It may show antibodies present in the blood but the person may not be suffering from the disease. People only end up spending unnecessarily,” said J N Banavaliker, director of Rajan Babu Institute of Pulmonary Medicine and Tuberculosis in New Delhi.
He explains that the blood test may give false positives and a person may be put on unnecessary TB drugs when he is not actually suffering from it. The test may also give negative result for a person suffering from TB and that may delay the treatment.
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