The Indian Council of Medical Research’s (ICMR) National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test, “COVID KAVACH ELISA”, for antibody detection for COVID-19, says an official communication from the Ministry of Health and Family Welfare. In order to manufacture the large quantities required, the Ministry has given the mandate to pharmaceutical giant Zydus Cadila headquartered in Ahmedabad.
Zydus Cadila is India’s fourth largest pharma company. The press release does not reveal the criteria on which the technology was passed on to this particular company, which has obviously led to raised eyebrows in some quarters. The spokesperson for another pharmaceutical company said bids were not invited for the technology. In such cases, the government protocol is to issue a tender.
“The scientists at ICMR-NIV, Pune, have enthusiastically worked to develop and validate the completely indigenous IgG ELISA test for antibody detection for SARS-CoV-2. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity. In addition, the test will have the advantage of testing 90 samples together in a single run of 2.5 hours. Moreover, ELISA based testing is easily possible even at district level as the ELISA kit has inactivated virus. There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test. The test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market,” said the release.
“While real time RT-PCR is the frontline test for clinical diagnosis of SARS-CoV-2, robust antibody tests are critical for surveillance to understand the proportion of population exposed to infection. Most of the diagnostic material for COVID-19 is imported into India from other countries. Therefore, Indian scientists are tirelessly engaged in developing indigenous diagnostics for SARS-CoV-2, the causative agent of COVID-19,” it added.
The Ministry said Zydus would partner ICMR as it was an innovation-driven global health care company and had the capacity to mass produce the kits. According to a news agency report, Lav Agarwal, the Joint Secretary in the Health Ministry, said Zydus was chosen because it has the wherewithal to do production at a faster pace. He added that other companies would be approached in some time.
Zydus has already applied for fast-track approvals for manufacture and commercial use of the kits so that it can be out in the market at the earliest. Incidentally, Zydus exports many of its products and has a strong presence in the United States and Europe, as well as in Latin America and Africa.