Covid-19 self-testing: ICMR gives nod to Meril, Mylab self-testing kits; safety of these kits explained

The kits can be easily used by people at home.

With a massive increase in Coronavirus cases during the second wave has surely impacted testing infrastructure. Delays in Covid-19 testing led to late detection in positive cases. Following this, the Indian Council of Medical Research (ICMR) has given a nod to self-testing kits including the one by Meril and one by Mylab. These kits are aimed at early detection of Coronavirus infection among people who are symptomatic. The kits can be easily used by people at home.

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On Thursday, ICMR gave approvals to Medtech company Meril that rolled out its self-use Rapid Antigen Test for Covid-19. Called CoviFind, the test has been indigenously developed and researched to detect the presence SARS-CoV-2 virus in people who have been infected. The idea is to allow detection early, so that immediate measures can be taken and other people in contact can also be informed. According to a report by The IE, the test results are delivered swiftly in 15 minutes. Priced at Rs 250, the test does not have any specific requirement for storage or refrigeration.

The test kit has a testing device, one sterile nasal swab as well as a pre-filled buffer tube with a cap. There is no need for an additional instrument. The kit will also have instructions for people to use where step-by-step procedure on administration is detailed and there is also information on how to handle the post-use disposal of the test.

Similarly, last month, ICMR had approved self-testing kits by Mylab. The testing kit by Mylab also has similar instruments to detect the presence of the virus.

Will ICMR self-testing kits relieve burden on testing labs?

The introduction of self-testing kits is expected to reduce the burden of testing labs to some extent but it is not going to be significant, said Sameer Bhati – Director at Star Imaging and Path Labs. According to Bhati, the antigen tests conducted are lower than RT-PCR. “We need to understand that these self-testing kits cannot substitute and be an alternative to the gold standard RT-PCR test because of the reason that these antigen kits have some limitations attached to it,” Bhati told FE Online.

He added that in cases where people are tested negative and are symptomatic, repeat testing will anyway have to be done via RT-PCR. “I believe that only during peak time, these self-testing kits may reduce the burden and that too in the cases when people are not willing to step out or cannot step out of their home for testing,” said Bhati.

Is it safe to use these self-testing kits?

The kit has passed all the quality tests and is approved by ICMR, but it is safe as long as it is used in accordance with the directions given in the manual and if the ICMR guidelines are followed. According to Bhati, in lab collections, the sample collection boys have been periodically given special training by the microbiologists on the techniques of sample collection. Therefore, challenges in terms of collection technique can arise when people are doing it themselves. “Apart from tracking and tracing, another challenge from a safety point of view would be the bio medical waste management. In our lab we strictly follow bio medical waste management rules. The government needs to make some guidelines on this and monitor its implementation for self-testing kits, otherwise it may pose a challenge in containment of the diseases,” Bhati added.