Two South Korean firms, Seegene and SD Biosensor have received government approval to supply RT-PCR based Novel Coronavirus (COVID-19) diagnostic kits in India. The government also approved 12 rapid antibody test kits for COVID-19 diagnosis. Seven of them are Chinese companies. Overall, 16 companies can now market their test kits in the country.
The advantage of antibody rapid tests is that the result can be made available within 30 minutes. The test comes positive after 7 to 10 days of infection. While a positive test indicates exposure to COVID-19, negative does not rule out the infection.
The approvals for antibody-based rapid kits were granted to BioMednomics (USA), Getein Biotech (China), Sensing Self Ltd (Singapore), Hangzhou Biotest Biotech (China), AmonMed Biotechnology Co (China), Beijing Tigsun Diagnostics Co Ltd (China), Biomaxima (Poland), CTK Biotech (USA), Hunan Lituo Biotechnology Co (China), Vivacheck Lab (China) and Wondfo (China).
Currently, the RT-PCR probes for diagnosis of COVID-19 are procured from the USA and supplied to government testing laboratories across the country. Recently the government had allowed two private companies – Indian company MyLab and German firm Altona Diagnostics – to supply COVID-19 test kits to both governments as well as private testing laboratories in India.
Thirteen kits have failed to clear the validation requirement of Indian Council of Medical Research (ICMR) and may have to try again for marketing approval for their test kits in India.