Private labs in the country have introduced uniform reduced prices of a WHO approved Tuberculosis (TB) diagnostic test thus paving way for more patients access to one of the worlds most accurate and reliable TB tests.
The gold standard for TB detection “ the MGIT Liquid Culture will be available at a subsidized ceiling price of Rs 900 (the maximum price laboratories can charge patients) at select labs registered with IPAQT (The Initiative for Promoting and Affordable Quality TB Tests), a coalition of over 60 private labs in India making WHO approved tests available at affordable prices to patients in the private sector. The cost varies between Rs 1100 “ Rs 2000 in other private labs. Currently WHO-endorsed tests are available at specially negotiated low prices only to the public 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 in determining which drugs can be used to treat patients. It is also more effective than conventional approaches in diagnosing TB in patients co-infected with TB and HIV.
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.
Laboratories play a central role in patient care and surveillance. Unfortunately, the capacity of labs to deliver the quality-assured diagnostic services needed for effective treatment of control of TB, and particularly the growing threat of drug-resistant TB, is severely limited. Lab strengthening with high end test such as Liquid Culture at affordable cost is critical for effective TB treatment and control, said Dr Shalabh Malik, Head, Microbiology, Dr Lal Path Labs and a member of IPAQT.
There are 4 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/hospitals and now has reached 61 labs (with over 3,000 collection centers) 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.
This initiative will make TB diagnosis more affordable for the private sector patients and improve the quality of TB care in the country. Any private healthcare setup with an accreditation from RNTCP, College of American Pathologists or National Accreditation Board for Laboratories can join the program and offer TB diagnosis at a subsidized rate, said Dr Jatinder Bhatia, Chief of Lab services, Metropolis Healthcare (International Chain of Diagnostics) and a member of IPAQT.
To promote understanding of this technology in India, private manufacturer Becton Dickinson (BD) is working with both Revised National TB Control Program and Foundation of Innovative New Diagnostics 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.
As per Dr Ranjan K Nanda, scientist, International Centre for Genetic Engineering and Biotechnology, The culture based test will remain as a gold standard and capacity building for the test 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.
Dr Vithal Prasad Myneedu, Sr Microbiologist & HOD, Dept Of Microbiology, LRS Institute of TB & Respiratory Diseases said, International TB laboratory experts also recommend the use of TB liquid culture systems in low-income settings. They are the standard of care for TB diagnosis in developed countries and will revolutionize the scenario in India once adopted widely.
India ranks #1 in the world and constitutes 1/5th of the global TB burden. Every year, in India close to 2 million people develop the disease with nearly 40% of them being infectious. As per WHO, India along with China contributes nearly 50% to the global burden of Multiple Drug Resistant TB (MDR-TB). It is estimated that more than 70% of Indians seek first contact medical care in the private sector and more than 50% of all TB patients in India are treated in the private sector. The WHO has discouraged blood tests for TB and in June 2012, the Government of India banned their use as they were highly inaccurate and provided misleading results.