The Indian Council of Medical Research (ICMR) has issued an advisory where it has given approval to a rapid antigen detection kit for COVID-19. The move by ICMR is expected to speed up the testing procedure in some cases, allowing the greater frequency of testing.
The detection kit, ‘Standard Q Covid-19 Ag Detection Kit’ is developed by South Korean bio-diagnostic company SD Biosensor that has a manufacturing unit in Gurugram. It is the standalone antigen detection test available in India that has been validated, yet.
ICMR has also implored other manufacturers and developers that have their own antigen detection tests to come forward and get them validated, in an effort to be used for COVID-19 detection.
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The ‘Standard Q Covid-19 Ag Detection Kit’ detection kit was evaluated independently by ICMR and All India Institute of Medical Sciences (AIIMS). The detection kit was found to have very high specificity, which is the ability to detect true negatives ranging and relatively low sensitivity, which is the ability to detect true positives. The test results can be obtained in about 15 to 30 minutes.
Taking note of the high specificity and low sensitivity of Standard Q Covid-19 Ag detection kits, the ICMR advisory outlines its use in combination with the gold standard RT-PCR test for individuals in containment zones, hotspots and healthcare settings. Samples will be collected by trained practitioners and tests will be conducted onsite under strict medical supervision within an hour of collection extraction buffer.
Most importantly, the ICMR notes that “suspected individuals who test negative for COVID-19 by rapid antigen test should be definitely tested sequentially by RT-PCR to rule out infection.” Additionally, in case of a positive test result, it will be considered as a true positive which does not need reconfirmation by RT-PCR test.
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