India-Made ELISA Kits Over 92.3 Percent Sensitive To Detect Coronavirus, Says ICMR

Indian Council of Medical Research’s (ICMR) study finds that India made IgG-based ELISA kits are highly sensitive for the detection of coronavirus infection in human serum samples.

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New Delhi: Indian Council of Medical Research’s (ICMR) latest scientific paper finds that India made IgG-based ELISA kits for COVID-19 testing is highly sensitive and specific for the detection of coronavirus infection in human serum samples. The ICMR has also said that the ELISA kit will be useful to screen healthcare workers, industry workers, and others who were exposed to the virus. Enzyme-linked immunosorbent assay (ELISA) tests are used to detect the production of antibodies in the body against a virus. According to a report by ANI, 513 blood samples were collected out of which 131 were positives and 382 were negatives. These were tested through the microneutralization test (MNT) which is the gold standard method for serological assay. The indigenous ELISA correlated accurately with neutralization assay which indicates that the assay was specific and sensitive for the detection of the COVID-19 virus. The findings also showed that there were no cross-reactivity with other respiratory virus and there was a difference in the performance while using serum or plasma. “The developed ELISA test was found to be 92.37% sensitive, 97.9% specific robust, and reproducible. The positive-negative values with 94.44 and 98.14 percent, respectively,” stated ICMR findings according to the report. According to the medical research body, for the surveillance of the emerging and reemerging viruses, serological assays have been widely recommended and many ELISA kits are being developed. The ELISA kits can be produced even at lower manufacturing costs. These kits which are usually less expensive than an RT-PCR test are easy to use and cost-effective for areas with lower resources. “Due to the non-availability of indigenous, approved, and cost-effective kits, an in-house ELISA was developed and validated for the detection of anti-SARS-CoV-2 human IgG antibodies,” read the paper according to the ANI report. The ICMR released a validated list of IgG ELISA kits to be used for serosurveys to understand the proportion of the population exposed to COVID-19. These IgG ELISA/CLIA tests which are US-FDA approved can be used directly after marketing approval from the Drugs Controller General of India (DCGI).