WHO approves TB diagnostic test at reduced price, IPAQT gears up to offer these services

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World Health Organisation (WHO) has now approved the gold standard for tuberculosis (TB) detection known as MGIT Liquid Culture to be made available at a subsidised ceiling price of Rs. 900. With this, select labs registered with Initiative for Promoting Affordable, Quality TB Tests (IPAQT), which is a coalition of over 60 private labs in India will have to make the WHO approved tests available at affordable prices to patients in the private sector.

Liquid culture is faster, more accurate and more comprehensive than conventional solid media or sputa smear approaches. It is particularly valuable in its ability not only to detect drug resistant TB (MDR/XDR-TB) but also more effective than conventional approaches in diagnosing TB in patients co-infected with TB and HIV.

The actual cost for TB detection varies between Rs. 1100 to Rs. 2000 in other private labs, however, WHO-endorsed tests are available at specially negotiated low prices only to the public sector. From now on, the TB patients can avail the benefits of one of the world’s most accurate and reliable TB tests approved by WHO, as private labs in the country have introduced them at a uniformly reduced prices.

In India, 73 private labs including 15 IPAQT labs and 50 government set ups are offering the liquid culture test. Labs in IPAQT, which operates on a high-volume, low-margin model have access to lower, negotiated prices for the quality tests in exchange of their commitment to pass on the benefits to patients.

“The threat from TB causing bacterium is growing because of microbe becoming increasingly drug resistant. Updating the labs with latest technologies such as liquid culture is a welcome step and crucial to control TB and making the treatment more effective,” stressed Dr Sujay Prasad, director-pathology, Anand Diagnostic Laboratory, Bengaluru.

There are four tests approved by WHO: LED microscope, liquid culture and two molecular tests viz. Gene Xpert and line probe assay. Molecular-based tests provide rapid and accurate results and are preferred choice. However, molecular-based tests are expensive and costs around Rs. 3,500 per person. As per a report published in PLOS medicine journal, the recently introduced Xpert MTB/RIF has limitations including limited shelf-life of the diagnostic cartridges, operating temperature and humidity restrictions, requirement for electricity supply, the need for annual servicing and calibration of each machine.

The IPAQT initiative was started in March 2013 with the backing of 14 labs and hospitals and now has reached 61 labs (with over 3,000 collection centres) in Feb 2014. The members of IPAQT have tested 45000 TB suspects through one or more of the WHO approved TB tests as of March 2014. TB cases diagnosed are notified to the Revised National TB Control Programme (RNTCP) for linkages to free TB drugs, where necessary.

“With the support of this initiative TB diagnosis will be affordable even in the private labs and thus will improve the quality of TB management. Any private lab approved by the National Accreditation Board for Laboratories or College of American Pathologists Revised National TB Control Programme can become a member and offer the service to the public,” Dr Prasad added.

To promote understanding of this technology in India, Becton Dickinson (BD) is working with both Revised National TB Control Program and Foundation of Innovative New Diagnostics (FIND) to develop capacity for TB culture and drug susceptibility testing in 33 laboratories across India. Under the initiative, best practices are being taught using BD BACTEC MGIT liquid culture systems, quality control and quality assurance of laboratory practices.

Dr Ranjan K Nanda, scientist, International Centre for Genetic Engineering and Biotechnology,said that the culture based test will remain as a gold standard and capacity building for such tests should be given high priority in every state of our country. TB and/or HIV incidence rates could be used as an important indicator for identifying locations to facilitate culture test.

Source: PharmaBiz

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