A multiplex RT-PCR kit for COVID-19 detection, which gives test results within two hours, developed by the Sree Chitra Tirunal Institute for Medical Sciences and Technology, was launched formally on a virtual platform on Tuesday by president of the Institute V.K. Saraswat.
The kit has been validated by the Indian Council of Medical Research (ICMR) at the National Institute of Virology, Pune. The validation shows that the kit has 97.3% sensitivity and 100% specificity in COVID-19 detection, an official press note issued by the SCTIMST said.
The SCTIMST has already signed a technology transfer agreement with Huwel Lifesciences, Hyderabad, which will now release the product commercially.
The kit developed by the SCTIMST targets two SARS CoV2 genes: RdRp and ORFb-nsp14, and the human RNAse P gene as the internal control. The kit is based on multiplex Taqman chemistry, amplifying all three genes in a single reaction. The amplification time for the assay is 45 minutes, besides the time required for the RNA isolation from nasopharyngeal swab samples, according to the official statement.
Various studies have shown that RdRp and ORF1b-nsp14 genes are more sensitive in detecting COVID-19. Using two highly accurate confirmatory genes like RdRp and ORF-nsp14 will give precise results.
Moreover, the ORF-nsp14 is one of the least mutated genes in COVID-19. This is one of the first kits in the market to have the ORF-nsp14 gene as the target in an RT-PCR kit. The product development was initiated by Anoop kumar Thekkuveettil and his team, according to the statement.
