Top medical body ICMR issues advisory for use of Feluda Covid test
Feluda uses CRISPR gene-editing technology to identify and target the genetic material of Sars-CoV2, the virus that causes Covid-19Updated: Oct 22, 2020, 22:27 IST
The Indian Council of Medical Research (ICMR) has issued an advisory for the use of FELUDA paper strip test, the country’s first indigenously developed test for coronavirus disease (Covid-19) based on the genetic editing tool CRISPR/Cas-9, which is likely to hit the market within a month.
According to the ICMR advisory, no further reverse transcription polymerase chain reaction (RT-PCR) based confirmation is required for samples that are confirmed as positives or negatives by it; specimen collection and transfer of sample for the test must be performed using appropriate personal protective equipment; and testing should be carried out under appropriate biosafety (BSL2 level) precautions, following the standard RT-PCR guidelines laid down by the medical body.
Feluda uses CRISPR gene-editing technology to identify and target the genetic material of Sars-CoV2, the virus that causes Covid-19. CRISPR, which is short for Clustered Regularly Interspaced Short Palindromic Repeats, is a gene-editing technology that can be used to detect a specific 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 approved by the Drug Controller General of India for a commercial launch.
The advisory also allows existing ICMR-approved government and private laboratories for SARS-CoV-2 RT-PCR based testing to be used for this new test. No further approval would be required from ICMR for starting the test in existing laboratories; however, new labs wanting to start the test will need 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 top medical body.
The kit has already been validated by the Department of Atomic Energy’s National Centre for Biological Sciences, Bengaluru.
The test is named after a fictional detective created by the late Satyajit Ray, although it is also 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 tests in over 2,000 patients during the trials at IGIB and on testing in private labs, the test showed 96% sensitivity and 98% specificity. This compares favourably to ICMR’s current acceptance criteria of RT-PCR Kit of at least 95% sensitivity and at least 99% specificity. Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify those without the disease (true negative rate).