Indian medical regulator approves new test kit for COVID-19 patients

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MUMBAI, Sept. 9 (Xinhua) — Indian medical regulator on Wednesday approved an Immunoglobulin G (IgG) based ELISA test kit for COVID-19 patients, said a joint statement by two companies, who developed the kit.

The use of an IgG antibody test offers the opportunity to study and understand the percentage of population exposed to SARS-CoV-2 infection, said the statement by HiMedia Laboratories, an Indian bioscience company and Syngene International, a global integrated research company.

ELISA stands for enzyme-linked immunoassay, which is a commonly used laboratory test to detect antibodies (protein) in the blood.

The kit called ELISafe 19TM is intended for qualitative detection of IgG SARS-CoV-2 antibodies.

The kit is expected to play a significant role in testing for SARS-CoV-2 antibodies facilitating tracking of the progression of infection and immunity to future infection, said Dr. Vishal Warke, Director R&D, Cell Culture and Immunology, HiMedia Laboratories.

This type of serological detection of SARS-CoV-2 antibodies will generate invaluable data and provide the basis for epidemiological studies of immunity in the community: a significant advance in the management of this highly infectious disease in India, said Dr. Mahesh Bhalgat, Chief Operating Officer, Syngene International Ltd.

As on Wednesday, India’s cumulative tests for detection of the virus has surpassed 50 million, while tests per million population have risen to 36,703.

India, ranked second after United States for the total number of cases, has 897,394 active cases of COVID-19 with 73,890 deaths reported so far. Enditem

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