Pune-based molecular diagnostics company Mylab Discovery Solutions, which launched the first indigenous RT-PCR testing kit, will also launch India's first self-use rapid antigen test (RAT) kit for Covid-19, at Rs250 per pack.
Mylab on Thursday announced that it has received approval from the Indian Council of Medical Research’s (ICMR) for the self-use rapid antigen test for Covid-19, CoviSelf.
This kit was developed in partnership with Gujarat-based LabCare Diagnostics, which is into clinical chemistry reagents, serology test, immuno-chromatographic tests and urine analysis strips.
CoviSelf, the self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases as per ICMR guidelines without the need for sample collection by healthcare personnel.
The test kits can be purchased without a prescription from local pharmacies and online channel partners. Mylab said this will ease pressure on already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country.
“The company will start shipping out tests within a few days. Mylab current production capacity is 7 million tests per week and plans to increase its capacity to 10 million tests per week within 14 days," the company said.
Each kit will have all testing materials, instructions for use (IFU) leaflet and a biohazard bag for safe disposal after testing. The test is designed to be done using nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort. CoviSelfTM will provide results in 15 min and people who test positive should immediately isolate so that they do not infect others and quickly contact a healthcare provider. Those who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider, the company said in a statement.
The testing will be monitored using Mylab’s mobile phone application, through which users are advised to click a picture of the test strip after completing the test procedure.
“This easy-to-use test combines with Myab’s AI-powered mobile app so that a user can know his/her positive status, submit the result to ICMR directly for traceability, and know what to do next in either case of result," Mylab director Sujit Jain said.
Dr Balram Bhargava, DG, ICMR, has said that these home testing Rapid Antigen Test kits will be available in the market in the next 3 to 4 days.
“For home testing for COVID19, one company has already made the application, and three are in the pipeline. Within a next week, we should have another three companies,” Dr Bhargava said.
Home testing by RAT is advised only in symptomatic individuals and immediate contacts of laboratory-confirmed positive cases.
ICMR said the home testing kits should not be used randomly, without careful judgment.
Individuals aged 18 years and above can take the test. For kids between the age of 2 and 17, an adult member is to collect the sample.