By Sharmeen Hakim, Mumbai Mirror | Updated: May 8, 2020, 07:25 IST

State dithers on antibody testing over accuracy and protocols

Residents queue up for Covid-19 screening in MazgaonBMC accepts donation of 1,000 ICMR-approved kits as experts and NGOs call for giving it a try.

Awaiting the arrival of around 40 lakh rapid antibody test kits from countries like South Korea and France, various states have started using the locally-manufactured kits approved by the Indian Council of Medical Research (ICMR). However, Maharashtra seems to be dithering on even inviting tenders from the available ICMR-approved firms. There are five such manufacturers, including one that assembles a South Korean kit in India.

Despite topping the national coronavirus tally with 16,758 Covid-19 positive cases, the state says it is still waiting for clarity on the accuracy of the kit following withdrawal of the reportedly faulty Chinese test kits. This is despite the last week’s order by the Nagpur bench of the Bombay High Court, which directed the state to undertake rapid antibody tests with available reliable kits provided by Indian companies.

A state-based NGO Hopes India wrote to the BMC on April 30, wanting to donate 1,000 antibody test kits manufactured by Medsource Ozone Biomedicals Ltd. However, the civic body reluctantly agreed to accept the donation when Mirror called officials yesterday. According to Medsource’s director Prateek Mittal, the firm has already sold over 150,000 kits to Punjab, Haryana and Jharkhand, while tenders have been issued by Kerala and Karnataka.

Caught between saving lives and livelihoods, the entire world is looking at multiple testing and treatment options to contain the spread of Covid-19. One of the testing options that has reportedly received green signals in almost every country, including India, is rapid testing of antibodies. Simultaneously detecting IgM and IgG antibodies to SARS-CoV2 that causes Covid-19, the test is likely to indicate if the person has been exposed to the virus.

Currently the RT-PCR (real time polymerase chain reaction) is considered a gold standard test as it detects the virus through throat or nasal swabs. However, costs and time involved have restricted testing across the country. The antibody test, on the other hand, is said to give results within 10-15 minutes in one-fourth the cost.

A rapid antibody test kit manufactured by Medsource
Explaining how the antibody test functions, Dr Trupti Gilada said while IgM antibodies are formed soon after an active infection, IgG antibodies are formed later and indicate if the person is immune. Dr Gilada is a physician at the Unison Medicare and Research Centre, a comprehensive healthcare service for infectious diseases.

She said it is impossible to run an RT-PCR for everyone in a containment zone or hotspot. “But if I conduct the inexpensive rapid test, IgM will indicate who needs to be quarantined and IgG will indicate the immune persons,” she said. This, she said, could be followed with an RT-PCR only on a select few. If the antibody test has been conducted on everyone in a containment zone then those who are immune can be allowed move freely, Dr Gilada added.

Dr. Pratik Jariwala, who owns a pathology laboratory in Borivali, said rapid antibody testing is still a grey area as India doesn’t have clear protocols in place. But he said that we would never know if we didn’t try. On this note, the deputy Director of the BMC’s health department, Dr Daksha Shah, said, “The ICMR must give approvals and issue protocols and additionally involve microbiologists to validate test kits.”

Rehan Dhorajiwala, founder of Hopes India, said the antibody test kits currently being used have to be approved by both the ICMR and the National Institute of Virology in Pune. “These approvals have already been granted for the kits we want to donate to the BMC. If you won’t start antibody testing, how are you likely to understand the accuracy,” he said.