India to launch World's first Paper Test Kit (FELUDA) for COVID-19 : Indian Health Minister

 

Indian scientists know how to convert adversities into opportunity. They have successfully developed, test and manufactured for commercial launch a Paper test kit (FELUDA) that could diagnose COVID-19 in just one hour. 

Indian Health Minister shared the good news of the rollout of the FELUDA Test in the near future. He said based on tests in over 2000 patients during the trials at the Institute of Genomics and Integrative Biology (IGIB) and on testing in private labs, the test showed 96% sensitivity and 98% specificity.

Which is at par with the ICMR’s current acceptation criteria of RT-PCR Kit of at least 95% Sensitivity and at least 99% Specificity, he stated. The Feluda paper strip test for SRS-CoV-2 diagnosis has been developed by CSIR-IGIB and has been approved by the Drug Controller General of India for a commercial launch.

The kit has already been validated by the Department of Atomic Energy’s National Centre for Biological Sciences, Bangalore. “While I cannot put an exact date on the availability, we should expect this test within the next few weeks”, he said.

The Paper test has been named after a famous Indian fictional detective and is based on a gene-editing technology called Crispr. Feluda is going to be commercially manufactured by a leading Indian conglomerate, Tata, and could be the world's first paper-based Covid-19 test available in the market.

"This is a simple, precise, reliable, scalable and frugal test," The Union Health Ministry said.  The best part of the test kit is that it has 96% sensitivity and 98% specificity. The accuracy of a test is based on these two proportions. A test that's highly sensitive would detect almost everyone who has the disease, and a test that has high-specificity will correctly rule out almost everyone who doesn't have the disease.

While the first ensures not too many false-negative results, the second not too many false positives. India's drug regulator has cleared the test for commercial use.

How Paper test kid would be a gamer changer

In the traditional PCR test, the sample is sent to an accredited laboratory where it has to go through a number of "cycles" before enough virus is recovered. But Feluda test uses Crispr - short form for Clustered Regularly Interspaced Short Palindromic Repeats - or a gene-editing technology to detect the virus.

World Over

While scientists world over is working on these lines and developing a paper-based technology for the test, they are nowhere close to India. In the US and the UK, several companies and research labs are developing similar paper strip tests which can be cheap and mass-produced.

One of the most talked-about has been a paper-based strip developed by Sherlock Bioscience which has been cleared for emergency use by the US Food and Drug Administration (FDA). The test claims to detect the "unique genetic fingerprints of virtually any DNA or RNA sequence in any organism or pathogen". DNA and RNA are sister molecules responsible for the storage of all genetic information that underpins life.

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