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Good Health, Fitness & Hygiene
{{contributorFullName}} | 29-11-2017
Yaathum Biotech has developed a semi-automated, rapid and affordable multiplex qPCR diagnostic test which can detect TB and a full range of drug resistance in TB. The point-of-care diagnostic assay compared to the current commercially available tests is more affordable, it is about one-third of the present cost. The technology is rapid, specific, sensitive and detects the full range of resistance.
The point of care diagnostic assay based on nucleic acid amplification of different targets, aim to identify the M. tuberculosis and detect the specific single nucleotide polymorphisms (SNP) most frequently associated with drug resistance. Compared to the currently available tests it is more affordable, it is about one-third of the present cost. It delivers rapid results in less than 2 hours, it is specific, sensitive and detects the full range of Drug resistance in TB and can be used at the microscopy-center level of the health-care system where no cold chain facilities or power supply or technical expertise is available. The assay also provides a platform to incorporate any newly identified mutations in future. The test does not require any biosafety facility and ensure non-degradation of samples in cold chain free transport. Correct and rapid detection of drug resistance facilitates appropriate and timely delivery of anti-TB therapy and reduces overall treatment costs. It reduces the increased difficulty in treating the disease and eliminates the high risk of the patient remaining infectious for a longer time thereby reducing the risk of direct transmission to public and healthcare workers. Customers/beneficiaries will be patients that show clinical symptoms of TB, diagnosed with TB, at high risk for TB, healthcare workers or close contacts and patients who do not respond to anti-TB treatment. Also Laboratories at national (or reference laboratory) level, the district level of the health system, part of schemes like RNTCP, DOTS, IPAQT, and STOP TB.
Drug-Resistant Tuberculosis (MDR and XDR-TB) emerges as a result of treatment mismanagement, due to misdiagnosis. Globally 440,000 persons had MDR-TB and one-third of them died (WHO-2008). 6.6% of patients with MDR-TB have XDR-TB which is virtually untreatable and resistant to Rifampicin, Izoniazid among first line anti TB drugs (MDR-TB) and any fluroquinolones, and at least one of three second-line drugs like amikacin. It is 100 times more expensive to treat MDR-TB than TB plus increased toxicity to patients. Inadequate therapy allows selection of spontaneous mutations in favor of resistant organisms leading to resistance to multiple drugs. Correct and rapid detection of drug resistance facilitates appropriate and timely delivery of anti-TB therapy and reduces overall treatment costs.
India has the highest TB burden in the world, amounting to 20% of the global burden of TB. In 2008, out of the estimated global annual incidence of 9.4 million TB cases, 1.98 million were estimated to have occurred in India and an estimated 1.4 million (15%) were HIV positive. Every day, more than 5,000 people develop TB disease and over 750 people die from it. TB kills more women and results in more orphans, compared to all other causes of maternal mortality combined. The risk of developing MDR-TB amounts to about 3% among new cases, and 12-17% among re-treatment cases; recently, this risk shows an increasing trend. Central TB Division- India (CTD) estimates that about 50,000 MDR-TB (detectable) cases occur in India annually out of which over 6.6% are XDR-TB and there is an increasing trend.The current rates of MDR-TB translate into an estimated annual incidence of 110,000 cases. Of the estimated half million with MDR-TB, only 8.5% are diagnosed and fewer than 4% are treated. This technology can make a huge impact through in India reducing TB mortality rates.
The novel multiplex real-time PCR assay can diagnose full range of drug resistance in a single test in less than 2 hours and is available at one-third the present cost.
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