ICMR issues Guidelines for Antibody Test Kits

On May 13, 2020, the Indian Council of Medical Research released guidelines for using rapid antibody kits for COVID-19. The Council has also listed the names of the manufacturers that produced these kits. It includes two Chinese manufacturers as well.

Highlights

The antibody tests according to the apex body are not recommended for diagnosis of COVID-19. The tests are to be used only for surveillance.

Issues

The licenses of the two Chinese companies that are now included in the list were cancelled by the Central Drugs Standard Control Organization. However, they have found their names in the list. The other companies included in the list were validated at NIV Pune.

Guidelines

The tests are to be done on plasma samples or serum samples or blood samples. The results of the tests will be available in 30 minutes.

Role of NIV

According to health research body, ICMR, the National Institute of Virology (NIV) has so far validated 42 antibody based rapid tests. Out of these 10 were manufactured in India.

Why are antibody test kits used only for surveillance?

Antibody kits are not used for confirming COVID-19 infection. They are only used for surveillance. This is because the chances of these kits producing false negatives are high at early stages of COVID-19.

Antibodies are generated only after 7 to 10 days of infection. So when tested prior to this, the tests show negative.

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