ICMR Recalls Covid 19 Rapid Antibody Test Kits – Free PDF

• Following the ‘South Korea model’, many states wanted to start mass testing using rapid tests.
• ICMR agreed on 4^th April and India imported almost one million rapid test kits from China to ramp up testing.
• On receiving complaints from various states, ICMR asked states to halt all rapid tests.

• On 27^th April, the Indian Council of Medical Research (ICMR) told the states that the newly procured kits for Rapid tests had failed quality checks and should be returned to the suppliers.

What is a rapid test?

• A test that takes less time than the 8-9 hours that the standard RT-PCR test result takes.
• In the Indian context, a rapid test means the serological tests with kits that India had imported from China, which have now failed quality tests.

RT PCR

• Reverse transcription polymerase chain reaction
• RT-PCR is a laboratory technique combining reverse transcription of RNA into DNA and amplification of specific DNA targets using polymerase chain reaction.
• This test looks to find the virus in nasal or throat swabs of the patient.

Rapid test

• Point of care immunodiagnostic tests
• Serological test
• The test usually looks for antibodies in the blood (serum), which the body develops to fight the virus.

What is Antibody?

• An antibody (Ab), also known as an immunoglobulin (Ig) is a large, Y-shaped protein  that is used by the immune system to neutralize pathogens such as pathogenic bacteria and viruses.
• Antibodies are secreted by B cells of the adaptive immune system
• The antibody recognizes a unique molecule of the pathogen (antigen), attaches to it and activates other parts of immune system to attack the ‘foreign’

Benefit of Rapid tests

• Quick – 15 min only
• Inexpensive – Rs. 300 to 600, compared to 4500 of RTPCR
• Doesn’t take a specialist to perform the test.
• The test is done by pricking a finger and putting some blood in it. (Similar to self pregnancy detection kits)
• Checkpoints , hotspots, large quarantine centres

What is the problem with detecting antibodies?

• Antibodies are produced over days to weeks after infection with the virus.
• The strength of antibody response depends on several factors, including age, nutritional status, severity of disease, and certain medications or infections like HIV that suppress the immune system.
• In some people with COVID-19, (confirmed by RT-PCR), weak, late or absent antibody responses have been reported.
• If a test is done too soon after a person is infected and the body hasn’t had time to develop the antibodies the test is designed to detect, it could miss an infection.
• But scientists don’t yet know enough about the timing of the body’s immune responses to SARS-CoV-2 to say exactly when specific antibodies develop.
• This is a first generation test developed in just 4 months and needs refinement.

WHO stand on rapid tests

• At present, based on current evidence, WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings.
• They should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available.
• The Health Ministry as well as the ICMR have reiterated several times that the “gold standard” for diagnosis is RT PCR, and the serological tests should be used only for the purpose of generating epidemiological data or for surveillance in hotspots.

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