Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of Defence Research and Development Organisation (DRDO), has developed an antibody detection-based kit ‘DIPCOVAN’, the DIPAS-VDx COVID-19 IgG Antibody Microwell ELISA for sero-surveillance.
The DIPCOVAN kit can detect both spike as well as nucleocapsid (S&N) proteins of SARS-CoV-2 virus with a high sensitivity of 97 per cent and specificity of 99 per cent. The kit has been developed in association with Vanguard Diagnostics Pvt Ltd, a development and manufacturing diagnostics company based at New Delhi.
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 was approved by Indian Council of Medical Research (ICMR) in April this year.
In May, it received regulatory approval from the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, to manufacture for sale and distribution.
DIPCOVAN is intended for the qualitative detection of IgG antibodies in human serum or plasma, targeting SARS-CoV-2 related antigens. It offers a significantly faster turn-around-time as it requires just 75 minutes to conduct the test without any cross reactivity with other diseases. The kit has a shelf life of 18 months.
It will be commercially launch during the first week of June. Readily available stock at the time of launch will be 100 kits (approx 10,000 tests) with a production capacity of 500 kits/month after the launch. It is expected to be available at about Rs 75 per test.
The kit will be very useful for understanding COVID‐19 epidemiology and assessing an individual’s previous SARS‐CoV‐2 exposure.
Union Defence Minister Rajnath Singh has appreciated the efforts of DRDO and the industry in developing the kit at the time of need.
Also Read | ICMR OKs rapid Covid-19 home-testing kit, advises on who should use
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