Conducting sero surveillance studies for Covid-19 will now be cheaper and easier with Indian defence scientists developing an indigenous antibody detection kit with high sensitivity and specificity.
Validation
The kit, developed by researchers at the Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of Defence Research and Development Organisation, has already undergone extensive validation using more than 1,000 patient samples at various Covid-designated hospitals in Delhi. It has already been validated by the Indian Council of Medical Research and has received regulatory approval of the Drugs Controller General of India, said a statement on Friday.
While the kit will be useful for epidemiological studies, which are conducted to ascertain exposure to the virus at community level, it could also be used by individuals suspected to have been infected by SARS-CoV2 virus to detect the presence of antibodies.
The technology for the DIPCOVAN kit has already been transferred to New Delhi-based diagnostics manufacturing company, Vanguard Diagnostics. The kit is said to have a high sensitivity of 97 per cent and specificity of 99 per cent.
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 turnaround 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.
Vanguard Diagnostics will commercially launch the product during the first week of June 2021. Readily available stock at the time of launch will be 100 kits (approximately 10,000 tests) with a production capacity of 500 kits/month after the launch. It is expected to be available at about ₹75 per test.
Commercially available kits, mostly imported, cost around ₹130 or more per test, said a scientist unconnected with the work.