Validation of rapid antigen detection tests for COVID-19: ICMR invites applications from manufacturers

New Delhi, Jun 25: The ICMR on Thursday invited applications for validation of rapid antigen detection tests for COVID-19 from all manufacturers who have developed such kits as part of its efforts to scale up testing capacity with faster diagnosis.

The rapid antigen test allows faster diagnosis without laboratory examination of samples and results are available within 30 minutes.

The ICMR has identified six sites -- AIIMS, Delhi; SMS Medical College in Jaipur; King George Medical University, Lucknow; Kasturba Hospital for Infectious Diseases, Mumbai; PGIMER in Chandigarh; Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry and NIV, Kerala unit, Alappuzha -- for validation of the rapid point-of-care antigen detection tests for coronavirus infection.

It has recommended deployment of rapid antigen detection test for COVID-19 in combination with the RT-PCR test in all containment zones, all central and state government medical colleges and government hospitals, all private hospitals approved by National Accreditation Board for Hospitals and Healthcare (NABH), all NABL-accredited and ICMR-approved private labs for COVID-19 testing.

According to the apex health research body, as India is lifting lockdowns in various parts of the country in a phased manner, it is expected to see an upsurge in cases of COVID-19 due to increased transmission of SARS-CoV-2 virus. In view of this, it is important to scale up testing capacity to the maximum possible levels, it said.

"The gold standard RT-PCR diagnostic test for COVID-19 has limitations in terms of widespread availability. In view of this, there is an urgent requirement of reliable and convenient rapid point of care antigen detection assays with high sensitivity and specificity. "Such assays could be used as potential diagnostic tests in all possible public and private healthcare settings and made available for mass testing," the body said in its 'Invitation for Expression of Interest for Validation of Rapid Antigen Detection Assays for COVID-19' document.

So far, ICMR has validated and approved only one rapid antigen detection assay from SD Biosensor, a South Korea based company, having its manufacturing unit in Manesar, Gurgaon.

"ICMR invites applications for validation of rapid antigen detection tests for COVID-19 from all manufacturers who have developed such test," it said.

A minimum of 300 rapid antigen tests would be required for each validation. Also, a minimum of 3-4 instruments (if the test results are to be interpreted using a specialized equipment such as fluorescence immunoassay readers etc.) will be required besides, having the ability to provide training to technical staff involved in validation of the test .

If the kit is approved after validation, the manufacturers should be committed to make adequate supplies of the product available to India with immediate effect.

Having an import / test license from CDSCO/DCGI would be an essential criteria wherever applicable, the document stated. All hospitals, labs, state governments intending to perform the point-of-care antigen test need to register with ICMR to obtain the login credentials for data entry.

India registered its worst single-day increase in COVID-19 cases on Thursday, recording close to 17,000 coronavirus infections pushing the overall tally to 4.73 lakh while the death-toll climbed to 14,894 with 418 new fatalities, according to the health ministry data updated at 8 am.