'Non-exclusive agreement' signed with Zydus-Cadila for the Covid-19 antibody test kit: ICMR
NEW DELHI: ICMR has signed a non-exclusive agreement with Zydus-Cadila, an innovation-driven healthcare company, to produce the Indigenous Antibody Detection Kit for Covid-19 after three other firms rejected the offer, the apex health research agency. Thursday.
In a statement, the Indian Medical Research Council said about external validation, IgG ELISA The test kit produced by ICMR and the National Institute of Virology (NIV) in Pune has been found to have a sensitivity and specificity of 98.7 percent and 100 percent respectively.
The ICMR said that, based on the potential of the companies, SPAN, J MITRA, Zydus-Cadila, they were offered to take over the production of the kit.
Except Zydus-Cadila, the three others refused to accept the offer. Cadila, which is an innovation-driven global health company, accepted to produce the ELISA. This have been named as Covid KAVACH ELISA, the ICMR said.
ICMR's statement comes after the Congress on Wednesday alleged a conspiracy behind the grant of license to manufacture ELISA testing kits to Zydus Cadila as it questioned the government's decision in creating a monopoly in this field.
The ICMR said it has signed a non-exclusive agreement with Zydus Cadila, which means the apex health research body continues to have the right to offer any other company which comes forward to take up the production of ELISA.
The ICMR said it has also been approved by Cipla Pvt Ltd. and Life Sciences for providing non-exclusive license for COVID KAVACH ELISA, which is under process.
The ELISA test has the advantage of processing 90 samples together in a single run of two-and-a-half hours, the ICMR said.
Moreover, ELISA -based testing is easily possible even at the district level as the test kit has inactivated virus. There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test, it said .
The ICMR further stated that this test has the advantage of having much higher sensitivity and specificity compared to the various rapid test kits.
While real-time RT-PCR is the first-line test for the clinical diagnosis of SARS-COV-2, robust antibody tests are critical to surveillance to understand the proportion of the population exposed to infection, he said.
The ELISA test would be used in a survey initiated by the ICMR in collaboration with other key stakeholders to estimate the prevalence of infection among the India n population, an ICMR official said.
The cross-sectional household-level survey to be conducted in 69 districts in 21 states and covering 24,000 adults can help determine if there has been a community-wide spread of the disease in those areas, an expert associated with the survey said.