A medical institute in Kerala has developed an RT-PCR kit with higher Covid detection accuracy. The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Kerala has developed a multiplex RT-PCR kit, having 97.3% sensitivity and 100% specificity in the Covid-19 detection.
This means it is unlikely to show any false positives and has only a 2.7% chance of showing a false negative.
The Indian Council of Medical Research (ICMR) has validated the RT-PCR kit at the National Institute of Virology in Pune and found it satisfactory.
The new multiplex RT-PCR 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.
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.
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 short-list possible new variants if one of the genes fails to amplify and can be marked for sequence analysis.
"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," the statement says.
The turnaround time using the kit developed by SCTIMST is also faster. A normal RT-PCR takes about five to six hours to be completed.
SCTIMST signed a non-exclusive license MoU with Huwel Lifesciences in Hyderabad on May 14 this year to commercialize the kit.
(With agencies input)
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