The ICMR has signed a "non-exclusive agreement" with Zydus-Cadila, an innovation-driven health company, for producing indigenous antibody detection kit for COVID-19 after three other firms refused the offer, the apex health research body said Thursday.
In a statement, the Indian Council of Medical Researchsaid on external validation, the IgG ELISA test kit produced by ICMR and National Institute of Virology (NIV) in Pune has been found to have sensitivity and specificity of 98.7 per cent and 100 per cent respectively.
The ICMR said based on the potential of companies, SPAN, J MITRA, Zydus-Cadila and Cipla were offered to take up the production of the kit.
"Except Zydus-Cadila, the three others refused to accept the offer. Zydus 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 licence to manufacture ELISA testing kits toZydus 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 approached by Cipla Pvt Ltd. and NextGen Life Sciences for providing non-exclusive license for "COVID KAVACH ELISA", which is under process.
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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 said this test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits.
"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 the infection," it 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 coronavirus infection among the Indian population, an ICMR official said.
The household level cross-sectional survey which would be conducted in 69 districts of 21 states and Union Territories and cover 24,000 adults can help ascertain if there has been community spread of the disease in those areas, an expert associated with the survey said.
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