Meril gets ICMR nod for indigenous Covid-19 self-test, CoviFind

New Delhi: Leading medical devices company, Meril’s self-use Rapid Antigen Test for Covid-19, CoviFind has received approval from the Indian Council of Medical Research (ICMR). This indigenously researched and developed test can detect the SARS-CoV-2 virus reliably in infectious individuals and can therefore be used for testing symptomatic individuals and immediate contacts of confirmed coronavirus cases as specified by recent ICMR guidelines.

Meril’s home-use rapid antigen tests will expand access to Covid-19 testing, while also helping the nation meet the demand for increased and frequent screening to curb the spread of Covid-19. The provision of high-quality rapid antigen testing will also enable access to screening in previously out-of-reach or under-equipped areas.

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. Prompt detection of cases is critical in ensuring isolation, tracing of immediate contacts and treatment if needed. The test also delivers results swiftly, providing accurate results in just 15 minutes. Additionally, the test does not have any specific storage or refrigeration requirements, thus driving ease and convenience in distribution.

The test is priced at ₹250 and will be made available as an affordable single-pack, with additional purchase options including a pack of 3, 5 and 25 tests. Each test kit is equipped with testing materials including a test device, one sterile nasal swab and a pre-filled buffer tube with a cap. No additional instrumentation is necessary. The kit will also contain an Instructions for Use (IFU) leaflet, detailing step-by-step procedure on administration, handling and post-use disposal of the test, along with a disposable bag. Following test usage, the nasal swab is to be inserted in the Lysis buffer tube provided, which deactivates SARS-CoV-2 and other viruses. The tube and other test materials should then be placed in the provided disposable bag, which offers a high level of biocontainment to ensure safe disposal.

The nasal swab offers a less invasive testing option and enables quick and convenient specimen collection while reducing discomfort, improving testing compliance. Nasal swabs only have to be inserted 2 to 4 centimetres (cms) into a patient’s nose, as compared to the alternative nasopharyngeal swab that needs to be inserted 8 to 10 cms into the nasopharynx  for adults.

The self-use test is to be used alongside the company’s official home testing mobile application, ‘CoviFind App,’ which will be available to download from the Google Play Store and Apple App Store once the product hits the market. The user-friendly app collects credentials and patient details, ascertains symptoms and offers a guided or quick test administration option. The guided test offers a step-by-step video breakdown of the process.

Users are advised to take a picture of the test strip, based on which the app swiftly provides information on the test result, leaving no room for error in interpretation. The AI-powered app easily differentiates between positive and negative results, as well as the intensity of a positive result, which may be missed or misinterpreted by the human eye. Results are then reported, and past results can be easily viewed through the app. Patients also have the option to share the data captured with their doctor.

Meril is employing a widespread distribution strategy to ensure access to rapid antigen testing across rural, semi-urban and urban regions of the country, including areas where laboratory testing options are limited. Self-use rapid antigen tests, administered in the absence of a healthcare practitioner and available over-the-counter, are central to a public health strategy of screening and routine testing. Equitable and cost-effective testing can also facilitate frequent testing across workplaces, schools and other institutions, which will become especially relevant and necessary as people return to normal activities.

The test will be available in two weeks at retail pharmacies, e-pharmacies and through e-commerce platforms including Amazon and Flipkart, with Meril trying to expedite the process. Meril will also run a dedicated website for direct orders of the test kit by individuals and institutions. A special 25-test kit option is available for institutions, corporations, schools and other large orders.

Commenting on the company’s efforts to expand testing solutions in India, Sanjeev Bhatt, Sr. Vice President, Corporate Strategy, Meril, said, “By making reliable rapid antigen testing available to all through a convenient format, Meril’s CoviFind test will facilitate early detection, isolation, treatment and contact tracing. This will limit the spread of infections, contributing to the nation’s ongoing efforts to quell the second wave of the pandemic. We are committed to producing our indigenously developed self-use test in high volumes to support India’s testing needs.”

He added, “We believe CoviFind will be a valuable tool to address the ongoing public health crisis while easing the burden on health systems and labs. This home test is the latest addition to our comprehensive Covid-19 testing portfolio, which has been supporting both public and private testing in the fight against the pandemic. We aim to continue contributing to the rise of self-reliance or Atmanirbharta in diagnostics.”

Meril has supplied a large number of tests across its Covid-19 diagnostics offerings pan-India, which span a multiplex RT-PCR test, KAVACH antibody tests in partnership with ICMR and now its rapid antigen test for at home self-use.