The home-based rapid antigen testing kit manufactured by Mylab Discovery Solutions Ltd, Pune, has been validated and approved by The Indian Council of Medical Research (ICMR). It said that for this rapid antigen testing, only a nasal swab would be needed, and that the procedure should be followed exactly as defined in the user manual by the manufacturer.
The ICMR issued an advisory cautioning people from using Rapid Antigen Tests (RATs) for indiscriminate home testing, stating that they could only be used on symptomatic persons and the immediate contacts of laboratory confirmed positive cases.
All individuals who test positive through the RAT kit may be considered as true positives and no repeat testing is required, the Indian Council of Medical Research said in the advisory
"All symptomatic individuals who test negative by RAT should get themselves immediately tested by RT-PCR. 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/Ministry of Health home isolation protocol while awaiting the RT-PCR test result," the advisory stated.
The ICMR stated that the home testing mobile app is available in the Google Play and Apple stores and that all users must download it. The mobile app is a comprehensive guide of the testing procedure and will provide a positive or negative test result to the patient. After completing the test process, all users are instructed to take a picture of the test strip using the same cell phone that was used to download the mobile app and user registration
“Data from your cell phone's app will be centralised in a stable server linked to the ICMR COVID-19 testing portal, where all data will finally be processed. Patient privacy would be respected to the fullest extent possible”, the advisory underlined.
Presently, CoviSelfTM(PathoCatch) COVID-19 OTC Antigen LF device manufactured by Mylab Discovery Solutions Ltd., Pune (Maharashtra), India has been validated and approved, the ICMR said.