Blanket ban on tuberculosis antibody tests after false results

A blanket ban on tuberculosis antibody tests has been ordered by the Union Health Ministry in India after the World Health Organization (WHO) reported that the tests have been giving false results.

The WHO raised the alarm about the tests after false results led to perfectly healthy individuals being put on powerful TB drugs. These mishaps became clear after the WHO reviewed 94 studies globally over a year ago, finding inaccurate tests to be present.

Deputy DG of the TB division of the Health Ministry Dr Ashok Kumar said: "It has been proven that these kinds of tests are neither consistent with their diagnosis nor give us the correct diagnosis of TB. So you are allowing the patient to suffer, complicate and transmit the disease. Number two, the cost has to be borne by the patient, a poor patient and they charge somewhere between Rs 880 to Rs 1200 a test, which is not useful and a patient is burdened with financial loss."

The researchers found both false negative and false positive results to be given by the TB anti-serology test. This means that not only can it hide the disease in a TB patient, but non-TB patients can test positive. This results in patients who test positive for the disease not being treated for the illness immediately, and patients who tested positive but actually didn’t have TB being put on powerful TB drugs, which can prove toxic for the liver, kidneys and brain.

According to the Indian government, there are 15 companies that sell 20 different antibody test kits. Dr Francois Decaillet of WHO said: "India is the first to ban these tests. This is a major public health problem."

The widely used DOTS programme in India doesn’t use the TB antibody tests, however, experts believe that at least 70 per cent of all TB patients go to a private doctor first and 90 per cent of private doctors prescribe these tests. India records 1.5 million new TB cases every year and has one-fifth of the global TB burden.

Posted by Neil Clark