Coronavirus | ICMR issues advisory for use of Feluda paper strip test
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It stated that no additional RT-PCR based mostly affirmation is required for samples which might be confirmed as optimistic or unfavourable by the CRISPR SARS-CoV-2 test.
The Indian Council of Medical Research (ICMR) has issued an advisory for the use of indigenously developed Feluda paper strip test, which relies on CRISPR-Cas9 know-how for analysis of SARS-CoV-2, by laboratories.
The paper-strip makes use of cutting-edge CRISPR gene-editing know-how 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 might be confirmed as optimistic or unfavourable by the CRISPR SARS-CoV-2 test, the advisory issued on Thursday acknowledged.
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 accepted by the Drugs Controller General of India (DCGI) for use 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 positive or negative by the CRISPR SARS-CoV-2 test,” the ICMR stated in its advisory.
Existing authorities or personal laboratories already accepted by the ICMR for SARS-CoV-2 RT-PCR based mostly testing might use this new CRISPR test if the laboratory wishes to take action.
No additional approval is required from the ICMR for current laboratories.
New laboratories desiring to provoke molecular testing of SARS-CoV-2 testing by any technique might be required to hunt approval as per the usual course of laid down by the ICMR and NABL earlier than initiating any type 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 primarily 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 in the course of the trials on the Institute of Genomics and Integrative Biology (IGIB) and testing in personal labs, the checks confirmed 96% sensitivity and 98% specificity.
This compares favourably to ICMR’s present acceptation standards of RT-PCR equipment of at the least 95% sensitivity and at the least 99% specificity, he had acknowledged.
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