The Indian Council of Medical Research (ICMR) on Thursday issued an advisory for the usage of indigenously developed Feluda paper strip check, which relies onCRISPR-Cas9 expertise for analysis of SARS-CoV-2, by the laboratories.
The paper-strip makes use of cutting-edge CRISPR gene-editing expertise to determine and goal the genetic materials of SARS-CoV-2, the virus that causes COVID-19 in lower than an hour. As claimed by the producer, no additional RT-PCR based mostly affirmation is required for samples which can be confirmed as constructive or destructive by the CRISPR SARS-CoV-2 check, the advisory said.
The check has been developed by Council of Scientific and Industrial Research’s (CSIRs) Institute of Genomics and Integrative Biology (IGIB), Delhi and has been validated by the National Centre for Biological Sciences and Tata Institute of Fundamental Research.
The check has been accredited by the Drugs Controller General of India (DCGI) to be used within the nation. “The test works by identifying SARS-CoV-2 virus strain and uses a Thermal Cycler instead of a qPCR machine for conducting the test. As claimed by the manufacturer, no further RT-PCR based confirmation is required for samples that are confirmed as positives or negatives by the CRISPR SARS-CoV-2 test, ” the ICMR stated in its advisory.
Existing authorities or non-public laboratories already accredited by the ICMR for SARS-CoV-2 RT-PCR based mostly testing could use this new CRISPR check if the laboratory needs to take action. No additional approval is required from ICMR for current laboratories.
New laboratories meaning to provoke molecular testing of SARS-CoV-2 testing by any methodology might be required to hunt approval as per the usual course of laid down by the ICMR and NABL earlier than initiating any form of molecular testing, the advisory stated. Any prescription for RT-PCR, CRISPR, TRUENAT, CBNAAT could also be thought of equal.
All testing information ought to be basically entered into the ICMR COVID-19 net portal on an actual time foundation. Union Health Minister Harsh Vardhan had not too long ago stated that based mostly on checks in over 2,000 sufferers throughout the trials on the Institute of Genomics and Integrative Biology (IGIB) and testing in non-public labs, the checks confirmed 96 per cent sensitivity and 98 per cent specificity.
This compares favorably to ICMR’s present acceptation standards of RT-PCR package of no less than 95 per cent sensitivity and no less than 99 per cent specificity, he had said.
