Abbott’s Covid-19 antigen test kits get ICMR nod

New Delhi, June 03: The Indian Council of Medical Research (ICMR) has given nod to the second home-based Rapid Antigen Test kit, developed by Chicago-based Abbott Rapid Diagnostics Division. The PanBio Covid19 Antigen Test Device, the self-use kit has been given provisional approval till July 5. After that, the pricing of the kit will be declared by the company.

ICMR had earlier given its approval to the CoviSelf test kit by Pune-based Mylab Discovery Solutions, which was priced at Rs 250 per kit.

In its advisory, the ICMR said that this should not be used indiscriminately.

• 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 playstore 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.