The Indian Council of Medical Research (ICMR) has issued an advisory for the use of indigenously developed Feluda paper strip test, which is based on CRISPR-Cas9 technology for diagnosis of SARS-CoV-2, by laboratories. The paper-strip uses cutting-edge CRISPR gene-editing technology to identify and target the genetic material of SARS-CoV-2, the virus that causes COVID-19 in less than an hour. As claimed by the manufacturer, no further RT-PCR based confirmation is required for samples that are confirmed as positive or negative by the CRISPR SARS-CoV-2 test, the advisory issued on Thursday stated. The test has been developed by the 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 the Tata Institute of Fundamental Research. The test has been approved by the Drugs Controller General of India (DCGI) for use in the country. “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 said in its advisory. Existing government or private laboratories already approved by the ICMR for SARS-CoV-2 RT-PCR based testing may use this new CRISPR test if the laboratory desires to do so. No further approval is required from the ICMR for existing laboratories. New laboratories intending to initiate molecular testing of SARS-CoV-2 testing by any method will be required to seek approval as per the standard process laid down by the ICMR and NABL before initiating any kind of molecular testing, the advisory said. Any prescription for RT-PCR, CRISPR, TRUENAT, CBNAAT may be considered equivalent. All testing data should be essentially entered into the ICMR COVID-19 web portal on a real time basis. Union Health Minister Harsh Vardhan had recently said that based on tests in over 2,000 patients during the trials at the Institute of Genomics and Integrative Biology (IGIB) and testing in private labs, the tests showed 96 per cent sensitivity and 98 per cent specificity. This compares favourably to ICMR’s current acceptation criteria of RT-PCR kit of at least 95 per cent sensitivity and at least 99 per cent specificity, he had stated.
