Nature Medicine (2020)
With support from the NIAID Centers of Excellence for Influenza Research and Surveillance, researchers from the Icahn School of Medicine at Mount Sinai report a new lab test to identify antibodies to SARS-CoV-2, the virus that causes COVID-19. Their findings are published online today in Nature Medicine. The test has been authorized for emergency use by the U.S. Food and Drug Administration.
Here, we describe a serological enzyme-linked immunosorbent assay for the screening and identification of human SARS-CoV-2 seroconverters. This assay does not require the handling of infectious virus, can be adjusted to detect different antibody types in serum and plasma and is amenable to scaling. Serological assays are of critical importance to help define previous exposure to SARS-CoV-2 in populations, identify highly reactive human donors for convalescent plasma therapy and investigate correlates of protection.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)—a member of the subgenus Sarbecovirus—has spread globally, causing a pandemic with, so far, 3.6 million infections and 250,000 fatalities (as of 5 May 2020).
Nucleic acid tests that detect the SARS-CoV-2 RNA genome are now widely employed to diagnose coronavirus disease 2019 (COVID-19). However, there remains a great need for assays that measure antibody responses and determine seroconversion. While such serological assays are not well suited to detect acute infections, they support a number of highly relevant applications. First, serological assays allow us to study the immune response(s) to SARS-CoV-2 in a qualitative and quantitative manner. Second, serosurveys are needed to determine the precise rate of infection in an affected area, which is an essential variable to accurately determine the infection fatality rate. ….read more: