New Delhi: The Centre has said that the new multiplex RT-PCR kit would further strengthen the COVID testing process and help India in its fight against COVID-19 amid the second wave of coronavirus in India.
The kit will help in detecting SARS-CoV-2 mutations and is developed by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an Institute of National Importance (INI) under the Department of Science and Technology (Government of India).
Ashutosh Sharma, Secretary, DST, said, "This unique RT-PCR kit will be a significant weapon in our fight against COVID-19 by a facile detection of SARS-CoV-2 mutations which are becoming increasingly important."
The Union Ministry of Science & Technology said that the kit targets two SARS-CoV-2 genes - RdRp and ORFb-nsp14, and the human RNAse P gene as the internal control to help detect a range of mutant strains.
"Various studies have shown that RdRp and ORF1b-nsp14 genes are more sensitive in detecting COVID-19. In order to target the multiple variants in the second wave, using two highly accurate confirmatory genes like RdRp and ORF-nsp14, can give precise results," the Union Ministry of Science & Technology added.
The ORFb-nsp14 is one of the least mutated genes in COVID-19 and currently, there are no kits in the market with ORF-nsp14 as the target.
It stated that the new kit is based on multiplex Taqman chemistry, amplifying all three genes in a single reaction. The amplification time for the assay is 45 minutes, apart from the time required for the RNA isolation from nasopharyngeal swab samples.
"Multiplexing two confirmatory genes will help shortlist possible new coronavirus variants if one of the genes fails to amplify and can be marked for sequence analysis," said the Union Ministry of Science & Technology.
The Indian Council of Medical Research (ICMR) has also validated this kit at the National Institute of Virology, Pune, and found that it has 97.3% sensitivity and 100% specificity in COVID-19 detection.
The SCTIMST has also signed a non-exclusive license MoU with Huwel Lifesciences, Hyderabad, on May 14 2021 to commercialize the kit.