Thermo Fisher Scientific, which is an international, firm, is planning to manufacture a novel testing kit for Covid-19 in Bengaluru.
The testing kit, to be called CoviPath, will be comprising of the assays and controls for RT-PCR testing. CoviPath has already been given the approval as per MDR 2017 rules for in-vitro diagnostic use by Indian Council of Medical Research (ICMR) and the Drug Controller General of India (DCGI) in all authorized laboratories.
The samples for the testing kit will be collected from the nasopharyngeal swab, nasopharyngeal aspirate and bronchoalveolar lavage (BAL). The testing with CoviPath will be initiated on Applied Biosystems real-time instruments with FAM dye, VIC dye and JUN dye or any RT-PCR platform holding a count of three dye channels approved for testing in molecular biology laboratories.
Amit Chopra, Managing Director, India and South Asia for Thermo Fisher Scientific iterated about 10 million tests could be manufactured by their Whitefield facility on a monthly basis.
Chopra said, “This facility will be instrumental in ensuring access to affordable testing kits while maintaining global quality standards,” further adding that the company is all set to ship the first batch of the testing kits. Chopra also emphasized on the fact that the kits will be only be used for India and no other country.
Chopra was further questioned about the need for the testing kits considering the rise of the vaccination drive in the country. To which he replied, “Testing will help to identify individuals who are pre-symptomatic or asymptomatic, thus limiting potential transmission. As economies gradually open, sustained testing strategy would play a critical role in controlling the spread of the virus. Further, the infrastructure for testing will allow the usage of precise molecular diagnostics in ensuring the country’s preparedness for future pandemics.”
CoviPath, as a testing kit, will be detecting viral targets with low mutations, and caters to high precision sensitivity (99.5%) and specificity (99.5%).
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