DRDO develops antibody detection-based kit for serological tests for SARS-CoV-2

Published : May 22, 2021 12:55 IST

Blood sample being taken for a serological survey for SARS-CoV-2. Photo: SUSHIL KUMAR VERMA

The Defence Research and Development Organisation (DRDO) announced on May 21 that it has developed an antibody detection-based test kit for the purpose of serosurveillance for SARS-CoV-2 infection. Called the DIPAS-VDx COVID 19 IgG Antibody Microwell enzyme-linked immunosorbent assay, or DIPCOVAN, it has been developed by DRDO’s Defence Institute of Physiology and Allied Sciences (DIPAS) in association with Vanguard Diagnostics Pvt Ltd.

Serosurveillance helps in estimating and ascertaining the spread of COVID-19 antibodies in a geographic area of the population and is an important component of disease surveillance.

A statement from the DRDO said that the DIPCOVAN kit can detect both a spike “as well as nucleocapsid (S&N) proteins of the SARS-CoV-2 virus with a high sensitivity of 97 per cent and specificity of 99 per cent”. Officials from the DRDO explained that an added advantage with DIPCOVAN is that it offers a significantly faster turn-around time as tests from the kit hardly taking 75 minutes to conduct and there are no cross-reactivity issues with other diseases. The DIPCOVAN kit has a shelf life of 18 months.

Vanguard Diagnostics Pvt. Ltd, a Delhi based, development and manufacturing diagnostics company, will launch DIPCOVAN commercially during the first week of June. Readily available stock at the time of launch will be 100 kits (approximately 10,000 tests) with a production capacity of 500 kits per month post the launch.

Defence Ministry officials stated that DIPCOVAN was intended for the “qualitative detection of IgG (Immunoglobulin G) antibodies in human serum or plasma, targeting SARS-CoV-2 related antigens”. They highlighted the fact that the development of the kit was 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 the last 12 months. The antibody detection kit was approved by the Indian Council of Medical Research (ICMR) in April 2021. In May 2021, the product received the regulatory approval from the Drugs Controller General of India (DCGI), the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare to go ahead with manufacture for sale and distribution.

Scientists at DIPAS opinioned that the DIPCOVAN kit would be very useful in “understanding the COVID‐19 epidemiology and assessing an individual’s previous SARS‐CoV‐2 exposure”.