Days after announcing that a Gujarat-based firm named Zydus Cadila would manufacture the ELISA COVID-19 test kits developed at the Indian Council for Medical Research-National Institute of Virology (ICMR-NIV), Pune, the government body has now declared that the technology is open to other pharmaceutical companies for production, too.
The Health Ministry had come under criticism for roping in the firm Zydus Cadila, and several firms had alleged that no open bids had been invited. However, in its announcement on Thursday, ICMR said that it had signed a 'non exclusive agreement’ with Zydus Cadila, “which means ICMR continues to have the right to offer to any other company (ies,) which comes forward to take up the production of ELISA.”
After the development of the test at ICMR-NIV Pune, four companies – SPAN, J MITRA, Cipla and Zydus Cadila – were offered to take up production based on their “potential”, the statement said. Zydus Cadila was the only firm to take up the offer, ICMR has claimed, stating that the other three firms refused the offer. The statement also said that ICMR has now been approached by two firms, Cipla and NextGen Life Sciences, for license to produce the tests.
The test, which has been named “COVID Kavach Elisa”, has been found to have sensitivity of 98.7% and specificity of 100%, the ICMR statement said. Earlier on May 11, Joint Secretary of Health Ministry Lav Agarwal had said that the test had a specificity of 97% and sensitivity of 92%.
“On external validation, the IgG test kit produced by ICMR-NIV, Pune has been found to have sensitivity and specificity of 98.7% and 100% respectively,” the statement said, adding that the first batch of tests produced by Zydus Cadila were found by NIV Pune to have similar sensitivity and specificity. “ICMR is in the process of carrying out a National Surveillance Study with 24,000 individuals,” the statement said.