The Indian Council of Medical Research has approved the first antigen-based coronavirus testing kit in India, Standard Q COVID-19 Ag Detection Kit. The test will allow patients to be diagnosed much faster, at lower rates and without laboratory examinations of the samples.

The kit developed by a South Korean biotechnology firm SD Biosensor has also been validated by AIIMS, New Delhi. The firm has a manufacturing unit in Manesar, Haryana.

The test is conducted on swabbed nasal samples that detects antigens found on or within the SARS-CoV-2 virus and is expected to provide the diagnostic result within 30 minutes.

The kit contains an inbuilt COVID antigen test device, viral extraction tube with viral lysis buffer and sterile swab for sample collection.

This comes as a significant development as currently, RT-PCR is the only standard frontline test for the diagnosis of Covid-19. Both of these tests detect the presence of viruses in the body, but differ in mechanisms, especially time.

Where the RT-PCR test takes a minimum of 2-5 hours, including the time taken for sample transportation, the antigen testing kit’s maximum duration for interpreting the test is 30 minutes.

The statement released by the advisory body further read that India will now have two kinds of tests, however, a person who tests negative through the antigen kit will still have to undergo the RT-PCR test for confirmation, The Indian Express reported.

The antigen test may not detect all active infections, as the sensitivity rate is lower than the PCR test.

‘Suspected individuals who test negative for COVID-19 byantigen test should be definitely tested sequentially by RT-PCR to rule out infection, whereas a positive test should be considered as a true positive and does not need reconfirmation by RT-PCR test,’ the advisory body as quoted.

Last month, the US Food and Drug Administration (FDA) authorised the first antigen testing kit called the Sofia 2 SARS Antigen FIA.

Around May 14, Japan’s Ministry of Health, Labour and Welfare approved the use of Tokyo-based Fujirebio Inc.’s antigen test kit.

In India, an independent two-site evaluation of this SD Biosensor kit was conducted at ICMR and AIIMS before approval.

The kit will currently be used in containment zones or hotspots, and is advised to be performed under strict medical supervision, and maintaining the kit temperature between 2° and 30°C.

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