The kit, which offers a sensitivity as well as specificity of over 99.5%, can detect viral targets with low mutations.
COVID-19 testing kits in India: Science firm Thermo Fisher Scientific has a new state-of-the-art manufacturing facility in Bengaluru, which is all set to give a push to indigenous technology in India’s fight against COVID-19. The facility would be producing COVID-19 testing kits as well as diagnostic solutions to be used in India, the company has said. The kits, called the CoviPath COVID-19 RT-PCR Kit, contain the assays as well as the controls for the gold standard RT-PCR test by Thermo Fisher that intends to qualitatively detect the nucleic acids from the SARS-CoV-2 (the novel coronavirus causing COVID-19) from the individuals suspected to be suffering from the infection.
The company also stated that its kit has been approved by the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India (DCGI) under MDR 2017 rules to be used for in-vitro diagnosis. This kit can be used in all authorised labs for testing on Applied Biosystems real-time PCR instruments using VIC dye, JUN dye or FAM dye. It can also be used on any RT-PCR platform having three-dye channels. The samples are collected using nasopharyngeal swabs, bronchoalveolar lavage (BAL) specimens, and nasopharyngeal aspirate, the company has said.
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Thermo Fisher Scientific managing director for India and South Asia Amit Chopra said that the company has been playing a key role in fighting the pandemic, and with these new kits and new facility, its commitment towards fighting the diseases in India has strengthened.
The facility in Bengaluru has a maximum manufacturing capacity of 1 crore tests a month, which means that it would be able to make access to affordable tests easier, Chopra added.
The kit, which offers a sensitivity as well as specificity of over 99.5%, can detect viral targets with low mutations. The kits come in a pack size of 200 reactions, and the company aims to make them available across the country by leveraging the distribution system it has.