New Delhi: Defense Institute of Physiology and Allied Sciences (DIPAS), a laboratory of the Defense Research and Development Organization (DRDO), has developed an antibody detection based kit ‘Dipcovan’, Dipas-VDX Covid-19 IgG antibody microwell ELISA, for sero-surveillance.
The DipCovan kit can detect both a spike of SARS COV-2 virus as well as nucleocapsid (S&N) proteins with 97 percent high sensitivity and 99 percent specificity. The kit has been developed in collaboration with Vanguard Diagnostics Pvt Ltd of New Delhi.
The Dipcovan kit has been developed by indigenous scientists and subsequently extensively validated on more than 1,000 patient samples in designated hospitals in Delhi. The verification work on three batches of the product has been done during the last one year. The kit was approved by the Indian Council of Medical Research (ICMR) in April 2021.
The regulatory approval to manufacture this product for sale and distribution was granted in May 2021 by the Controller General of Drugs of India (DCGI), Central Pharmaceutical Standards Control Organization (CDSCO), Ministry of Health and Family Welfare.
Dipcovan aims to qualitatively detect IgG antibodies in human serum or plasma that target the antigen related to SARS COV-2. This provides a significantly faster turn-around-time as it requires only 75 minutes to perform the test without any cross reactivity with other diseases. The shelf life of the kit is 18 months.
Industry partner Vanguard Diagnostics Pvt Ltd will commercially launch the kit in the first week of June 2021. The readily available stock at the time of launch will be of 100 kts (about 10,000 tests) and after launch it will have a production capacity of 500 kts / month. It is expected that it will be available at Rs 75 per check. This kit will be very useful to understand Covid-19 epidemiology and to evaluate the exposure of first SARS COV-2 in person.
Defense Minister Rajnath Singh has appreciated the efforts of DRDO and industry in developing the kit at the time of need.
Dr. G. Satish Reddy, Secretary, Department of Defense Research and Development and Chairman of DRDO, praised the team involved in developing the kit and said that the move will help people during the epidemic.