The ICMR issued guidance on rapid antibody test kits for COVID-19 and listed their manufacturers, which include two Chinese firms whose importer licenses were cancelled by the CDSCO after kits supplied by them showed wide-variation under field conditions.
In its guidance, ICMR stated that these rapid antibody tests are not recommended for the diagnosis of COVID-19 infection. The testing technique is used to detect antibodies in the blood of people who may have had coronavirus infection.
The tests will be done on plasma samples or serum samples or blood samples. The results of the tests will be available in 30 minutes.
So far, 42 antibody-based rapid tests has been validated at the National Institute of Virology (NIV), Pune.
The antibody test kits are used only for surveillance as there are high chances of these kits producing false negatives at the early stages of COVID-19.
The list of firms includes Abbott Laboratories Zydus Cadilla, HLL Lifecare Limited, India, and SIDAK Life Care Pvt. Ltd, among others.