ICMR suggests rapid antigen kits for speedier diagnoses

NEW DELHI : The Indian Council of Medical Research (ICMR) on Monday validated the first point of care rapid antigen diagnostic test for coronavirus disease (Covid-19) that gives results in 30 minutes as compared to the five hours taken by a conventional reverse transcription polymerase chain reaction (RT-PCR) test -- making it easier for health departments to test widely and quickly, and hospitals to screen non-Covid patients being admitted, especially for surgeries.

The test , the world’s first rapid test , can be used in field settings in containment zones, hot spots and hospitals, and its findings do not need to be confirmed through an RT-PCR test. The kit— Standard Q COVID-19 Ag detection kit—has been developed by SD Biosensor, a South Korean company and jointly validated by ICMR and All India Institute of Medical Sciences, Delhi.

The Central Drugs Standard Control Organisation has approved its import and manufacturing in the country.The company is yet to begin mass production of these kits in India.

“We have just got ICMR validation, so production will take some time. We will start manufacturing, may be around next week but the date has not been finalised yet. The price has also not been decided as yet but it will be cheaper than RT-PCR kits,” said Punit Kumar, deputy manager, regulatory affairs, SD Bio Sensor.

An RT-PCR test kit costs anywhere between ₹1,000 and ₹1,900 per piece.

“…Such tests would help in proper implementation of the Govt. strategy to test, track and treat. Such tests will also help in allaying the anxiety and fear of health care workers and aid in better clinical management of the patients…,” said ICMR in a statement.

“We have issued an advisory to the states that it can be used for diagnosis of Sars-Cov-2 and test results that return positive using this antigen based test don’t require reconfirmation through RT-PCR. States can procure the kit and use it. ICMR has provided the broad guidelines and the rest is up to the states to see how well it can be deployed on ground,” said Dr Lokesh Sharma, scientist and spokesperson, ICMR.

THE STANDARD Q COVID-19 AG DETECTION KIT HAS BEEN DEVELOPED BY SD BIOSENSOR, A SOUTH KOREAN COMPANY AND VALIDATED BY ICMR