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Genbody gets ICMR approval for antigen test kits

Mumbai: Global Diagnostic firm Genbody Inc has received approval for Indian Council of Medical Research and Drugs Controller General of India to supply its antigen test kits in India, named as “Genbody Covid-19 AG”. The medical diagnostic firm has partnered with Mumbai-based “Vishat Diagnostic” to distribute the test kits in India.

The test yields specificity of 98.0% and sensitivity of 90% and accuracy of 94.0% making it one of the most accurate antigen tests in India, the release said. It also successfully validated the stringent ICMR criteria for antigen tests approval.

“India is one of the most affected countries due to Covid-19. With such a large population, it is not easy to get people tested and isolated. Genbody Covid-19 kit can help to detect the infection with its high accuracy. To further accelerate the process we have partnered with Vishat Diagnostic to supply antigen rapid testing kits in India,” said Dr. C.K. Chong, Chief Technology Officer, Genbody Inc.

Genbody Covid-19 AG produces results within 15 minutes after the hospital takes a sample from the patient’s nasal or throat with a swab. The kit is a point of care test, performed within or outside conventional laboratory settings. Samples should be collected via nasopharyngeal route and tested within one hour of sample collection.

Vishat Diagnostic, MD Pratik Chitalia said, “We are happy to associate with the global diagnostic firm Genbody to supply high accuracy antigen test kits in India. Along with RT-PCR testing, this will strengthen our product offering to fight the pandemic with full force. ”

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