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This is an archive article published on March 28, 2020

ICMR guidelines for antibody kits: Not recommended for diagnosis

The Indian Express on March 26 had reported about the limitation of the serological test - that it can only be used for screening, and that patients will have to undergo the RTPCR test for diagnosis of COVID-19 infection.

india lockdown, coronavirus lockdown, covid 19 lockdown, SARS-CoV-2, indian express People carry essential items in Shimla on Day 3 of the nationwide lockdown. (Express Photo: Pradeep Kumar)

The Indian Council of Medical Research (ICMR), which has approved twelve antibody kits, on Friday issued guidelines on the use of these kits for testing for COVID-19, stating that the test “is not recommended for diagnosis” and that positive test would only “indicate” an exposure to the coronavirus.

The six guidelines issued by ICMR on the rapid antibody kits state that the test can be done on blood/serum/plasma; the test result is available within 30 minutes; test comes positive after 7-10 days of infection; the test is not recommended for diagnosis of COVID-19 infection; positive test indicates exposure to SARS-CoV-2; and a negative test does not rule out COVID-19 infection.

Read| ICMR to double testing laboratories for coronavirus

The Indian Express on March 26 had reported about the limitation of the serological test – that it can only be used for screening, and that patients will have to undergo the RTPCR test for diagnosis of COVID-19 infection.

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“The advantage is that the antibody test is very simple. Just a drop of blood is required and the results will be available in just one-two hours. Some kits require whole blood and some kits require blood to be centrifuged. However, one needs to remember that is not a test that will definitely tell you that a person is infected with COVID-19 infection. It is only for screening,” Dr V Ravi, Head and Senior Professor, Department of Neurovirology, NIMHANS had told The Indian Express.

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Dr Ravi had said the serological test will only help screen more number of suspected patients in a shorter duration but is not aimed to be a tool for mass testing.

“A positive test in the antibody will tell you that you have been exposed to the virus; and a negative test does not rule out COVID-19 infection, especially if it is very early after exposure. The reliability of such a test, in general, is seven days after the virus has entered the human body. The kit will clearly say what is the probability and at which point it is definite,” Dr Ravi had said.

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Kaunain Sheriff M is an award-winning investigative journalist and the National Health Editor at The Indian Express. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, an investigation into one of the world’s most powerful pharmaceutical companies. With over a decade of experience, Kaunain brings deep expertise in three areas of investigative journalism: law, health, and data. He currently leads The Indian Express newsroom’s in-depth coverage of health. His work has earned some of the most prestigious honours in journalism, including the Ramnath Goenka Award for Excellence in Journalism, the Society of Publishers in Asia (SOPA) Award, and the Mumbai Press Club’s Red Ink Award. Kaunain has also collaborated on major global investigations. He was part of the Implant Files project with the International Consortium of Investigative Journalists (ICIJ), which exposed malpractices in the medical device industry across the world. He also contributed to an international investigation that uncovered how a Chinese big-data firm was monitoring thousands of prominent Indian individuals and institutions in real time. Over the years, he has reported on several high-profile criminal trials, including the Hashimpura massacre, the 2G spectrum scam, and the coal block allocation case. Within The Indian Express, he has been honoured three times with the Indian Express Excellence Award for his investigations—on the anti-Sikh riots, the Vyapam exam scam, and the abuse of the National Security Act in Uttar Pradesh. ... Read More

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