The Indian Council of Medical Research (ICMR) has issued an advisory for the use of the FELUDA paper strip test, the first test developed in the country for coronavirus disease (Covid-19) based on the CRISPR gene editing tool. / Cas-9, which is likely to hit the market within a month.
According to the ICMR advisory, no additional confirmation based on reverse transcription polymerase chain reaction (RT-PCR) is required for samples that are confirmed positive or negative; sample collection and transfer of the sample for testing should be done using appropriate personal protective equipment; and the tests must be carried out under adequate biosafety precautions (BSL2 level), following the standard RT-PCR guidelines established 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 piece of DNA from a sequence.
The paper strip test has been developed by the Scientific and Industrial Research Council of the Institute for Genomics and Integrative Biology (CSIR-IGIB) and has been approved by the Comptroller General of Medicines of India for commercial launch.
The notice 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 from the ICMR would be required to begin testing in existing laboratories; however, new laboratories wishing to initiate testing will need to apply for ICMR approval.
“Any prescription of RT-PCR, CRISPR, TRUENAT, CBNAAT can be considered equivalent. All test data must essentially be entered into the ICMR COVID-19 web portal in real time. Other reporting mechanisms must also be guaranteed to the state and IDSP in accordance with the established protocols for reporting cases of COVID-19 ”, says the advisor to the highest medical body.
The kit has already been validated by the National Center for Biological Sciences of the Bengaluru Department of Atomic Energy.
The test is named after a fictional detective created by 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 on over 2,000 patients during testing at IGIB and on tests in private laboratories, the test showed a sensitivity of 96% and a specificity of 98%. This compares favorably with the current ICMR acceptance criteria of the RT-PCR kit of at least 95% sensitivity and at least 99% specificity. Sensitivity is the ability of a test to correctly identify people with the disease (true positive rate), whereas test specificity is the ability of the test to correctly identify people without the disease (true positive rate). negative).
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