The Defence Research and Development Organisation (DRDO) on Friday said it had, in collaboration with a company, developed an antibody detection kit for spotting SARS-CoV-2 virus with a high sensitivity of 97% and specificity of 99%.
“The DIPCOVAN kit was developed indigenously by the scientists, followed by extensive validation on more than 1,000 patient samples at various COVID designated hospitals in Delhi. Three batches of the product were validated during last one year. The antibody detection kit is approved by Indian Council of Medical Research (ICMR) in April 2021,” it said in a statement.
In May 2021, the product received the regulatory approval of the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, for manufacture, sale and distribution.
The Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of the DRDO, developed the kit in association with Vanguard Diagnostics Pvt. Ltd., a development and manufacturing diagnostics company based in New Delhi.
DIPCOVAN was intended for the qualitative detection of IgG antibodies in human serum or plasma, targeting SARS-CoV-2 related antigens and offering a significantly faster turnaround time as it required just 75 minutes to conduct the test without any cross-reactivity with other diseases. “The kit has a shelf life of 18 months,” the statement said.
Vanguard Diagnostics would commercially launch the product in June first week, the DRDO said. Readily available stock at the time of launch would be 100 kits (approx. 10,000 tests) with a production capacity of 500 kits a month after the launch. “It is expected to be available at about ₹75 a test.” The kit would be very useful for understanding COVID‐19 epidemiology and assessing an individual's previous SARS‐CoV‐2 exposure, it added.
