New Delhi: After almost two months of halting rapid antibody testing for Covid-19 in India, mass-scale testing for Covid-19 antibody is likely to begin from July.
The mass-scale testing for Covid-19 antibody is going to be conducted using the indigenously developed ELISA test kits developed by the National Institute of Virology (NIV-Pune). The ICMR has validated seven Indian companies for manufacturing these test kits. The antibody test is done to ascertain if an individual had contracted Covid-19 infection in the past by looking for such antibody in the blood of the individual. The test is done to find out how the body’s immune system responds to and tackles the infection and if the infection is still there. This helps scientists understand who all are immune to the virus, how sick it can make people, etc.
Earlier in April, the government had procured around 8 lakh rapid antibody test kits from China for testing Covid-19 antibodies, but had to recall all those test kits from different states in the last week of April after several states complained of faulty results being delivered by the kits.
However, the indigenously developed ELISA—enzyme-linked immunosorbent assay—antibody test is a kind of blood test, which is used to detect the presence of the Covid-19 antibody in the blood of the individual to ascertain whether the individual was infected with Covid-19. This test is similar to the rapid antibody tests, but unlike the rapid antibody tests, the ELISA antibody test is a laboratory-based test to find a Covid-19 antibody.
The companies that have been validated for manufacturing the ELISA antibody test kits include Gujarat-based Zydus Cadila Healthcare Ltd and Meril Diagnostics Pvt Ltd; Mumbai-based Voxtur Bio Ltd and Trivitron Healthcare Pvt Ltd. While two companies from Delhi—J. Mitra & Co. Pvt Ltd and Karwa Enterprises Pvt Ltd—have also been given the nod by ICMR for manufacturing these ELISA antibody test kits. Another Haryana-based firm, Avecon Healthcare Pvt Ltd has also been given responsibility for manufacturing these test kits.
The Sunday Guardian spoke to five out of these seven companies and apart from Zydus Cadila Healthcare Ltd, all the other six companies are waiting for the final nod from the ICMR for mass-scale production of ELISA.
Rajesh Agarwal, director of Avecon Healthcare Pvt Ltd, told The Sunday Guardian that the production of ELISA test kits is likely to begin in the next 20 to 25 days.
“We are in the process of manufacturing the ELISA test kits and some approvals from the ICMR are still pending. The technology has been transferred to us by the ICMR and we are in regular touch with the apex medical research body. These are regulatory issues and will be sorted out soon,” Rajesh Agarwal said.
Agarwal added that once mass-scale production of these test kits is done, his company would be able to deliver about 1 lakh such test kits per day.
Dr Vivek Verma, head operations, Karwa Enterprises Pvt Ltd, told The Sunday Guardian that his company would be able to start production in the next 15 days as some procedural issues were going on with the ICMR and once those were completed commercial production would start.
“Consultation process with the ICMR is on and within the next 15 days, we would be able to go for mass-scale production of ELISA antibody test kits. ELISA test kits are like the rapid antibody test kits and it can be tested in any laboratory in India as laboratory technicians are already trained with this technology. This is, however, not a confirmatory test, but to ascertain whether an individual had the Covid-19 infection. And it is quite fast as within two hours, we can test 96 to 100 samples in a particular machine,” Dr Vivek Verma said.
Officials from Trivitron Healthcare Pvt Ltd and Voxtur Bio Ltd have also confirmed to The Sunday Guardian that they are in the process of manufacturing these test kits and would be able to go for mass scale production by the first week of July.
The ICMR has recently conducted a sero survey amongst the high risk population in different containment zones across the country using the ELISA antibody test kits manufactured by Zydus Cadila Healthcare Ltd and according to Vivek Kant Tripathi from Zydus Cadila Healthcare Ltd, they have already supplied a couple of batches to the ICMR for conducting sero survey and will be doing so further as well.