Top medical body ICMR issues advisory for use of Feluda Covid test

The Indian Council of Medical Research (ICMR) has issued an advisory for using FELUDA paper strip test, the nation’s first indigenously developed test for coronavirus illness (Covid-19) based mostly on the genetic enhancing device CRISPR/Cas-9, which is more likely to hit the market inside a month.

According to the ICMR advisory, no additional reverse transcription polymerase chain response (RT-PCR) based mostly affirmation is required for samples which might be confirmed as positives or negatives by it; specimen assortment and switch of pattern for the test have to be carried out utilizing acceptable private protecting gear; and testing ought to be carried out underneath acceptable biosafety (BSL2 degree) precautions, following the usual RT-PCR pointers laid down by the medical physique.

Feluda makes use of CRISPR gene-editing know-how to determine and goal the genetic materials of Sars-CoV2, the virus that causes Covid-19. CRISPR, which is brief for Clustered Regularly Interspaced Short Palindromic Repeats, is a gene-editing know-how that can be utilized to detect a selected snippet of DNA from a sequence.

The paper strip test has been developed by the Council for Scientific and Industrial Research- Institute of Genomics and Integrative Biology (CSIR-IGIB) and has been accredited by the Drug Controller General of India for a business launch.

The advisory additionally permits current ICMR-approved authorities and personal laboratories for SARS-CoV-2 RT-PCR based mostly testing for use for this new test. No additional approval could be required from ICMR for beginning the test in current laboratories; nonetheless, new labs wanting to start out the test might want to apply for ICMR approval.

“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. Other reporting mechanisms to the state and IDSP should also be ensured as per the laid down protocols of COVID-19 case reporting,” says the advisory from the highest medical physique.

The equipment has already been validated by the Department of Atomic Energy’s National Centre for Biological Sciences, Bengaluru.

The test is known as after a fictional detective created by the late Satyajit Ray, though additionally it is an acronym for FNCAS9 Editor-Linked Uniform Detection Assay. It has been developed by senior scientists Dr Debojyoti Chakraborty and Dr Souvik Maiti at CSIR-IGIB.

Based on assessments in over 2,000 sufferers throughout the trials at IGIB and on testing in non-public labs, the test confirmed 96% sensitivity and 98% specificity. This compares favourably to ICMR’s present acceptance standards of RT-PCR Kit of not less than 95% sensitivity and not less than 99% specificity. Sensitivity is the power of a test to appropriately determine these with the illness (true positive price), whereas test specificity is the power of the test to appropriately determine these with out the illness (true detrimental price).