Gujarat-based Meril Diagnostics has announced that its self-use rapid antigen test kit for coronavirus, CoviFind, has received approval from the Indian Council of Medical Research, The Hindu reported on Thursday.
“The CoviFind test for at-home self-testing is highly effective in individuals with mid to high viral load, especially in detecting infection in the case of individuals more likely to transmit the disease to others,” the company said in a statement.
On its website, Meril Diagnostics has said that the kit, which involves use of nasal swabs, can be used for adults, as well as children above the age of two. A positive test result should be considered as a true positive and does not need reconfirmation through RT-PCR test, the company said.
However, in case of negative test results, it should be combined with clinical observations, patient history, and epidemiological information. Those who test negative for Covid-19 should also conduct an RT-PCR test to rule out the infection, Meril Diagnostics said.
The company has also released a video with instructions on how to use the kit.
The test delivers results in 15 minutes and does not have any specific storage or refrigeration requirements. Each kit will include a test device, one sterile nasal swab and a pre-filled buffer tube with a cap, the company said, according to The Hindu.
The test kit will cost Rs 250 and will be made available as a single-pack, with additional purchase options including a pack of 3, 5 and 25 tests. The test kit will be available in two weeks at retail pharmacies and e-commerce platforms.
On May 19, the ICMR approved the country’s first rapid antigen test kit manufactured by Pune-based Mylab Discovery Solutions. The medical research body had said that the testing kit was advised for use only on symptomatic individuals and immediate contacts of laboratory-confirmed positive cases.
Rapid antigen tests are considered less sensitive than lab-based RT-PCR tests. This means that some results from the RAT may show false negatives – wrongly indicating that the infection is absent. However, experts believe that their accuracy of the tests increase when the viral load is high.