Fusing journalism and TB – telling the stories as they are

GOI ban on serological tests. We want action – now

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On July 20, 2011, WHO urged countries to ban inaccurate and unapproved blood tests and instead rely on accurate microbiological or molecular tests, as recommended by WHO for detection of TB. The use of currently available commercial blood (serological) tests to diagnose active tuberculosis (TB) often leads to misdiagnosis, mistreatment and potential harm to public health, said WHO in a policy recommendation.

“In the best interests of patients and caregivers in the private and public health sectors, WHO is calling for an end to the use of these serological tests to diagnose tuberculosis,” said Dr Mario Raviglione, Director of WHO Stop TB Department. “A blood test for diagnosing active TB disease is bad practice. Test results are inconsistent, imprecise and put patients’ lives in danger.”

Almost a year later, on June 6, 2012, the Government of India (probably the first and only country in the world), issued a notification banning serological tests. This is a commendable move on the part of Government of India, but one that needs prompt follow-up and diligent enforcement. JATB decided to find out through a small exercise in one city (Bangalore), what the position was with regard to enforcement of the ban.

I called around ten laboratories, both large and small, to find out. Here are the findings…

I spoke to the senior most people available at each laboratory and barring one, none of the other laboratories had any knowledge about the ban. They were not aware about the WHO recommendation either. All the labs, without an exception, said that they continued to receive requests from general practitioners prescribing blood tests to detect TB, indicating a similar lack of awareness among them (general practitioners). On an average, each lab said they received around 30-35 requests per month. The tests cost Rs 700/- per antibody – an expense to the patient which has now proved to be completely avoidable.

Dr R Veena, Head of Laboratory Services, Elbit Laboratories, said, “A number of general practitioners prescribe these tests. We know that the tests are not accurate as they have low sensitivity and specificity, but we will continue to service the requests for these tests as long as doctors prescribe them.”

The next logical step was to ask some general practitioners for their views.

This was something of a shocker. As the labs declined to reveal the names of the doctors who were prescribing the tests, I had no opportunity to talk to those doctors. But I spoke to over 10 other general physicians. All of them emphatically said that blood tests were inaccurate and they did not rely on them at all. So who was prescribing them? What emerged was confusion and lack of clarity on the situation.

On the one hand, both laboratories and doctors agree that the tests are not accurate and hence not of much use in the diagnosis of TB. On the other, there is continued demand from doctors and labs continue to conduct these tests, as is evident from my interaction with labs. Patients continue to bear avoidable expenses on diagnostic tests that are not going to result in benefits.

The question to ask therefore is – where does the buck stop? Who must take responsibility for putting an end to this bad practice? It is obviously the government and probably National Accreditation Board for Testing and Calibration Laboratories (NABL), an autonomous body under the aegis of Department of Science & Technology, Government of India, whose mission is “To strengthen the accreditation system accepted across the globe by providing high quality, value driven services, fostering APLAC/ILAC MRA, empanelling competent assessors, creating awareness among the stake holders, initiating new programs supporting accreditation activities and pursuing organisational excellence.”

JATB requested answers from NABL about what was being done to ensure compliance to the ban. Dr Anil Relia, Director, Accreditation of PT Providers, in an unedited email interaction responded thus, “This WHO as well as GOI ban on serological tests for TB is already in knowledge of NABL. Subsequent to this notification, we have stopped accreditation of these tests. This has even been included in our draft NABL 112.”

Dr Relia, this is not enough. Given the ambitious mission of NABL, it is evident that achieving it will require a lot more than just intention. Action and quickly at that, is imperative. Patients deserve it – as a lay person, I don’t even look for NABL accreditation when I go to a lab for a test. My choice of labs is dictated by what my doctor recommends. So if your mission also includes creating awareness among stakeholders, I stake my claim to be educated and protected from all kinds of exploitation. And given the alarmingly high figures for TB in India, there is an even greater need for strict enforcement of the GOI ban.

JATB appeals to the Government of India, RNTCP and the Central TB division to, on a priority send out the ban notification to all the labs in India. It is not enough to issue press releases – more, much more action is required.

Bharathi Ghanashyam

Written by JournalistsAgainstTB

July 5, 2012 at 12:32 pm

Posted in TB and Media

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