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(CNN) – India’s drug authority last month approved a paper strip test for COVID-19 that shows results in less than an hour, the head of the government institute that invented the test told CNN on Monday.
The test, called FELUDA, an acronym for FNCAS9 Editor-Limited Uniform Detection Assay, was named after a popular Indian fictional detective. It is intended to “address the urgent need for accurate mass testing,” according to a statement from TATA Sons, which manufactured the test.
The kit could be manufactured for self-tests in the future, according to Agarwal, but the prototype currently being developed is only intended to be tested in labs.
The FELUDE test follows a similar rapid test kit developed in the USA this spring. Both tests use a gene editing technology called CRISPR to detect the virus in a patient’s RNA. The US Food and Drug Administration approved the emergency use of the SHERLOCK test kit in May, developed by the Massachusetts Institute of Technology.
The test received approval for commercial launch by India’s Controller General of Drugs, the country’s pharmaceutical authority, on September 19. It had a sensitivity of 96% and a specificity of 98% for detecting the new coronavirus, according to the Indian Council of Medical Research (ICMR). quality reference, according to a statement from the Ministry of Science and Technology. The sensitivity of a test indicates the probability of false negative results; its specificity indicates the probability of false positive results.
“This marks a significant achievement for the Indian scientific community, moving from R&D to high precision, scalable and reliable testing in less than 100 days,” the statement from the Ministry of Science and Technology said.
The test “is simple to administer and to interpret, allowing results to be available to the medical fraternity in relatively less time compared to other testing protocols,” said Banmali Agrawala, president of Infrastructure and Defense and Aerospace at Tata. Sons, in a statement.
Beyond administering the test, the result takes another 15 minutes. This means the entire test can be completed in about less than an hour, according to Agrawal.
The Indian kit was created in the constituent laboratory of the Council for Scientific and Industrial Research, which is part of the Institute of Genomics and Integrative Biology (CSIR-IGIB) in New Delhi. It was then shared with Tata Sons for production and manufacturing.
“Reliability is always measured by existing methods,” Agrawal, CEO of CSIR-IGIB told CNN on Monday. He attributes the test’s high levels of precision to a molecular diagnostic method called PCR (polymerase chain reaction), which detects the virus itself. Rather, a blood test would detect antibodies against the virus produced by the body.
India has suffered the second highest number of COVID-19 cases in the world and has seen more than 100,000 deaths since the pandemic began.
This story was first published on CNN.com, “India’s drug authority approved COVID-19 test on strips of paper that could return results in an hour”
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