ICMR approves antigen- based testing kit for faster diagnosis

Indian Council of Medical Research (ICMR) has recommended the use of the first antigen-based testing kit for the faster diagnosis of COVID-19. The kit will facilitate diagnosis at lower rates and without the laboratory examinations of samples.

The antigen test has been developed by a private biotechnology firm named SD Biosensor. Apart from ICMR, the test has been validated by AIIMS, Delhi. The test can detect the presence of SARS CoV2 in the swab collected from the nose.

In an advisory, ICMR recommended the use of antigen tests in combination with the gold standard RT-PCR Test. While no confirmatory tests have been required for samples testing positive, ICMR mentioned that those who tested negative must undergo RT-PCR test to rule out infection.

What the antigen test will do?

The test will be able to detect the presence of molecules of the pathogens that trigger an immune response in COVID-19 infected persons. The maximum time for diagnosing a positive or a negative result is 30 minutes through an antigen-based kit.

The test will be significant as the use of antigen kits will boost testing because of its turnaround time and pricing. Officials have mentioned that the test is going to be cheaper as compared to RT-PCR kits. Currently, around 1.5 lakh RT-PCR tests have been conducted in the country every day.

ICMR approves antigen-based testing kit:

In the light of rising demand for testing, ICMR has also asked the manufacturers to come forward for validation, who have antigen detection assays.

The agency mentioned that the testing kits will be used for all the symptomatic people with influenza-like illness (ILI) in hotspots or containment zones and asymptomatic and high- risk contacts with co-morbidities of confirmed cases.

In the hospitals, the kit will be used for the symptomatic ILI patients as well as asymptomatic patients who have been hospitalized or seeking hospitalization for chemotherapy and the transplants or those who are over 65 years of age with co-morbidities.

US FDA approves antigen-based test:

In May 2020, the US Food and Drug Administration had also approved an antigen-based test, mentioning that it is a new type of diagnostic test.

The agency had informed that each category of the diagnostic test has its own unique role in fighting the virus. PCR tests have been incredibly accurate but running tests and analysing the result takes time. One of the major benefits of an antigen-based test is its speed which will provide results in minutes.

US FDA also mentioned that the antigen test may not be able to detect all the active infections and the test is not as sensitive as the molecular PCR tests. It means that positive results are highly accurate but there is also a chance of false negatives. So it must be understood that negative results do not rule out infection and must be confirmed with PCR tests.