New Covid-19 testing kit to be made in Bengaluru

Thermo Fisher Scientific, an international firm, will be manufacturing a new Covid-19 testing kit in Bengaluru.

The kit, which has been titled CoviPath, contains the assays and controls for RT-PCR testing. The company said that CoviPath had been approved under the MDR 2017 rules for in-vitro diagnostic use by the Indian Council for Medical Research (ICMR) and the Drug Control General of India (DCGI) in all authorised laboratories.

Testing with the kit can be done on Applied Biosystems real-time PCR instruments with FAM dye, VIC dye and JUN dye or any RT-PCR platform with three dye channels in molecular biology laboratories approved for testing. Samples are collected from nasopharyngeal swab, nasopharyngeal aspirate and bronchoalveolar lavage (BAL) specimens.

Amit Chopra, managing director, India and South Asia, Thermo Fisher Scientific, said that their new manufacturing facility in Whitefield could manufacture up to 10 million tests every month.

"This facility will be instrumental in ensuring access to affordable testing kits while maintaining global quality standards," Chopra said, adding that the company is ready to ship the first kits. The kits are intended for use only in India, the company clarified.

However, considering the rollout of the vaccine, Chopra was asked if India required a new testing kit in the market.

"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," he said.

CoviPath is said to be able to detect viral targets with low mutations, and offers more than 99.5% sensitivity and 99.5% specificity.