09 August 2021 | News
The US-FDA approved antigen-based COVID-19 Home/Self tests are exempted from ICMR validation
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Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health, and Family Welfare, Government of India has recently issued a notification on the validation of COVID-19 Home Testing using Rapid Antigen (Ag) Tests (RATs). The US-FDA approved antigen-based COVID-19 Home/Self tests are exempted from ICMR validation.
To date, six Rapid Ag-based Home / Self Test Kits have been validated. These are Mylab Discovery Solutions, Pune for CoviSelfTM (PathoCatch) COVID-19 OTC Antigen LF device; Abbott Rapid Diagnostics Division, Chicago (Alere Medical, Gurugram) for PanBio COVID-19 Antigen Rapid Test Device and Meril Diagnostics, Vapi (Gujarat), for CoviFind COVID-19 Rapid Ag Self Test.
The other validated Rapid Ag-based Home/self Test Kits kits but not yet approved by ICMR are as follows: Trivitron Healthcare for MyCoviTest Self Test Kit, Oscar Medicare, Delhi for OSKIT Corona Ag Home Test and Oscar Medicare, Haridwar (Uttarakhand) for OSKIT Corona Ag Home Test.