U.S. FDA Authorizes Use of SARS-CoV-2 Neutralization Antibody Test in Convalescent Plasma Screening
New Jersey-based GenScript USA Inc. announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This FDA authorization request was filed on November 6, 2020.
As of February 9, 2021, the FDA had authorized 323 coronavirus diagnostic tests, including 240 molecular tests, 69 antibody tests, and 14 antigen tests during the COVID-19 pandemic. Furthermore, 35 molecular authorizations can be used with home-collected samples.
This is the first commercially available test to detect neutralizing antibodies in patient samples without using a live virus and measures the presence of neutralizing antibodies in patients recovering from COVID-19 or receiving a vaccine.
The conventional method for measuring neutralizing antibodies in patient samples requires testing to be performed in a high safety-level facility staffed with specialized personnel. Typically, results from the live virus assay are available in several days. Due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize.
In contrast, the cPass™ kit utilizes pure proteins produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard laboratories with a reduced turnaround time (~1hr), making it broadly available and much more consistent between various facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass™ assay shows that both tests are strongly correlated.
"Unlike commercially available antibody-based tests that are routinely used for detecting prior exposure to the virus, the cPass™ kit can assess both prior exposure and the presence of neutralizing antibodies in convalescent patients," commented David Martz, vice president of new product management in Life Science Group at GenScript, in a press release.