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Enforcement of the ban on serological tests for TB – where are we?

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It is common knowledge now that 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. On June 6, 2012, the Government of India (probably the first and only country in the world), issued a notification banning serological tests. So far so good.

We have evidence that at least 1.5 million serological tests performed in India every year. At $10-$30 per test, the cost of testing, plus the cost of TB drugs wasted on treating hundreds of thousands of patients with false-positive results, rival the entire Indian TB control program annual budget of $65 million. Every major private laboratory in India offers TB serological tests, mostly ELISA kits imported from developed countries that do not allow these tests to be used on their own TB patients. Notwithstanding the ban, private medical practitioners still rely heavily on these tests.

According to a recent article published in BioSpectrum, this situation remains unchanged even months after the ban. The article quotes the union minister of state for health, Mr Abu Hasem Khan Choudhary, “The tests approved by the Revised National Tuberculosis Control Program (RNTCP) for diagnosis of TB include sputum microscopy, X-ray chest, solid and liquid culture methods and rapid molecular tests. Available evidence indicates that, besides the tests mentioned above, the private sector heavily depends on the serological tests for diagnosis of TB.”

Dr Madhukar Pai, associate professor, McGill University, Canada feels that there is no valid, accurate test for TB using blood as the sample. He says in the BioSpectrum article, “Nowhere in the world is active TB diagnosed using blood specimens. So, from that perspective, there is no real alternative. There is a FDA approved, acceptable blood test for latent TB infection (not active TB), which is called as QuantiFERON TB Gold (marketed in India as “TB Gold”). Some big labs have started replacing antibody serology tests with this TB Gold, but that is a big problem. TB Gold cannot separate latent infection from active TB and therefore will show “positive” results for a large number of Indians.”

Then why are doctors prescribing this test? Can one bad test be replaced by another test that does not do what it is supposed to do i.e. accurately diagnose active TB?

JATB did an email interview with L. Masae Kawamura, M.D. Senior Director, Medical and Scientific Affairs, QuantiFERON, Global, QIAGEN. The interview is reproduced below:

Q1. You have spoken to 25 TB experts and clinical microbiologists in the Delhi area to assess the use/misuse of the test. You and your team found that the test had been used inappropriately, but that it was not widespread. Do you think 25 was an adequate number for a country the size of India, in order to reach this conclusion?
A1. Yes, I do because it matches other proprietary sources of data that we have and the fact that the official ban on serologic tests was fairly recent (June 2012) and there is usually always a lag in implementation, especially when there are lingering stocks.

Q2. What was the profile of people you spoke to?
A2. Most were highly experienced clinical microbiologists from medium and large private, academic and public laboratories. Others included expert rheumatologists, a pediatrician, diabetes specialist, a well-respected IVF gynecologist, clinical researchers, Gates Foundation (consultant to RNTCP) and the RNTCP.

Q3. Will you kindly update me on what you will be doing to give them more clarity on when to use your test, as you found that this clarity was wanting when you spoke to them?
Q4. Do you plan to expand this initiative because it is important to know what is happening in other regions of India?
A3&4. Aside from the caution label on product cartons and laboratory results, in March, QIAGEN will be supporting a round table discussion in Mumbai on the appropriate QFT use and smaller forums with key opinion leaders and experts in Chennai, Bangalore, and Delhi. Dr. Tony Catanzaro, UCSD professor, TB expert and consultant to QIAGEN will also be giving a talk to the Association of Practicing Pathologists in Delhi. The emphasis will be on screening and prevention of TB, the importance of latent infection diagnosis and using QFT appropriately. I also plan to work with the RNTCP by exploring synergistic strategies using QFT screening of key at-risk populations by the private sector. Our work in India this spring will help expand our knowledge on what is going on the ground and as important, help us to develop a relationship with the private sector that will hopefully enhance RNTCP TB control efforts in India.

While JATB appreciates the prompt response and efforts of Qiagen, there was a slight sense of discomfort that there appeared to be a condoning of the fact that labs continued to use bad tests simply because they had ‘lingering stocks’. After all we know of cases where mobile phones, cars and white goods have been withdrawn from the market when they are found to have defects. Here we are talking of tests that can spell the difference between cure and possible death for people who are seeking diagnosis. To top it we have a ban on these tests. Shouldn’t they be withdrawn from the market immediately?

We also appeal to Qiagen to widen their efforts to spread awareness on when to best use the QuantiFeron TB Gold test. Even one inappropriate use will mean injustice to patients who deserve better. JATB also strongly appeals to the Government of India to strictly enforce the ban on serological tests. We have waited long enough and want to see some action now.

Bharathi Ghanashyam

Written by JournalistsAgainstTB

February 16, 2013 at 1:59 pm

Posted in TB and Media

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