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Soon, ban on blood tests to detect TB by Kounteya Sinha

India will soon ban blood tests to detect tuberculosis (TB) that are widely available across the country. 

An expert group set up by the Drug Controller General of India has found that blood tests are mostly inaccurate for TB detection. It has recommended to the Union health ministry to immediately ban them. 

A ministry official said "The DCGI had set up an eight-member committee to look at whether a proposal by the World Health Organization of banning blood tests for TB was accurate and whether these kits can be trusted. The committee has said it is not advisable to use a blood tests and hence should be banned." 

Experts said not only do these blood tests fail to accurately diagnose TB, they aren't even cost effective as compared to the standard culture test provided free by the government. 

DCGI said, blood tests more often test positive when the patient does not have TB (false positive) and test negative when the patient actually has TB (false negative). 

Dr Sarman Singh, who heads the microbiology department at AIIMS, said, "Inaccurate blood tests are rampant for TB diagnosis in India. It is also expensive: over Rs 4,000 for the three blood tests. Inaccurate test results are making patients, who are TB-free, go through unnecessary treatment, while others are not even being offered treatment because the tests show they are TB negative when they are actually positive." 

A published study in 2010 estimated that in India $47.5 million (out of patients' pockets) are spent on serological tests, most of which miss many TB cases. 

The study estimated that 1.5 lakh patients were incorrectly declared TB positive, who were prescribed unnecessary treatment in 2010 after undergoing a blood test. 

With the disease infecting an estimated 2.3 million people in 2010 alone and killing 3.6 lakh - nearly 1,000 deaths per day with one in six deaths being those aged 15-49, early and effective diagnostics is of vital importance for India. 

According to Dr Ashok Kumar, head of India's revised national TB control programme, none of the serological tests available in the market at present "have published evidence to support their claims of sensitivity and specificity usually in excess of 95% each, according to package inserts. They provide no quality assurance and tests from different labs on specimens from the same patient often yield widely varying results." 

WHO in its first-ever negative policy recommendation recently called on governments to immediately ban blood tests to detect TB. Mario Raviglione, director of WHO Stop TB department, said blood tests lead to misdiagnosis and mistreatment. WHO said "It is strongly recommended that these commercial tests not be used for the diagnosis of pulmonary and extra-pulmonary TB. Currently available commercial serological tests provide inconsistent and imprecise findings." 

According to WHO, the high proportions of false-positive and false-negative results can have an adverse impact on the health of patients. Each blood test can cost up to $30 per patient. 

According to Dr Sarman Singh and Dr V M Katoch who is the chief of the Indian Council of Medical Research, there are more than 73 manufactures of TB serological test kits. There are at least 24 TB rapid test kit manufactures from China alone followed by the USA. India has eight rapid test manufacturers. 

"The claims of every manufacturer are extremely tall and misguiding. All Indian manufacturers have claimed high accuracy. Indeed all these claims are based on in-house or small studies with no proper validation. Sensitivity or ability to diagnose true TB cases is very critical and any test which has lesser detection rate than sputum microscopy does not warrant serious attention," they said. 

They added "The WHO expert group while deciding to issue a policy to ban all serological tests for TB diagnosis after analyzing the data of 67 publications, observed that even for pulmonary tuberculosis, the sensitivity was highly variable ranging from as low as 0 to 100%."