Priced at Rs. 250, the manufacturer will start shipping out kits within a few days
New Delhi: The Indian Council of Medical Research (ICMR) has approved a home kit for COVID-19 home testing using Rapid Antigen Tests (RATs). Mylab Discovery Solutions – the company that gave India its first RT- PCR test a year ago, announced today that it has received ICMR’s approval for India’s first self-use Rapid test for Covid-19. The test is developed in India and is named as CoviSelfTM.
Priced by the company at Rs. 250, the self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases as per ICMR guidelines. Users of this test will not need sample collection by a healthcare professional. 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 stated it will start shipping out tests within a few days. Mylab current production capacity is 70 lakh tests per week and plans to increase its capacity to 1 Crore tests per week within 14 days.
With CoviSelfTM, Mylab aims to make testing reach doorstep of every Indian to help them fight the second and any subsequent waves of pandemic. Now, any citizen can test for Covid-19 themselves, isolate and seek treatment quickly. Early detection can help save thousands of lives and significantly reduce burden on hospitals. The test can be purchased without a prescription from local pharmacies and online channel partners, the company said.
Each kit will be provided with all testing materials, instructions to use (IFU) leaflet and a biohazard bag to safely dispose 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.
ICMR has meanwhile issued the following advisory for the test:
- Home testing by RAT is advised only in symptomatic individuals and immediate contacts of laboratory confirmed
positive cases. - Indiscriminate testing is not advised.
- Home testing should be conducted as per the procedure described by the manufacturer in the user manual
(pictorial and video link of the user manual is provided below against the name of the approved test kit). - The home testing mobile app is available in Google play store and Apple store and must be downloaded by all
users. - The mobile app is a comprehensive guide of the testing procedure and will provide a positive or negative test
result to the patient. - All users are advised to click a picture of the test strip after completing the test procedure with the same mobile
phone which has been used for downloading the mobile app and user registration. - Data in the app of your mobile phone will be centrally captured in a secure server which is connected with the
ICMR COVID-19 testing portal, where all data will be eventually stored. - Patient confidentiality will be fully maintained.
- All individuals who test positive may be considered as true positives and no repeat testing is required.
- All test positive individuals are advised to follow home isolation and care as per the ICMR & Ministry of Health
& Family Welfare (MoH&FW) protocol which can be accessed at: https://www.icmr.gov.in/chomecare.html. - All symptomatic individuals who test negative by RAT should get themselves immediately tested by RTPCR. This
is especially important as the RATs are likely to miss few positive cases presenting with a low viral load. - All RAT negative symptomatic individuals may be treated as suspect COVID-19 cases and are advised to follow
the ICMR/MoH&FW home isolation protocol while awaiting the RTPCR test result. - All results may be interpreted as per the protocol laid down by the manufacturer in the user manual (pictorial
and video link of the user manual is provided below against the name of the approved test kit). - Manufacturer’s instructions must be strictly followed for disposal of the test kit, swab and other materials.
– global bihari bureau
