FDA

Neutralizing Antibodies Detection Test for COVID-19 Gets the FDA Greenlight

Innovative new COVID-19 tests continue to emerge from the pipeline. One of the products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody Detection Kit from Piscataway, NJ-based GenScript Biotech, which recently became the first commercial laboratory test using neutralizing antibodies to detect COVID-19 to gain Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Neutralizing Antibodies Detection

Neutralizing antibodies prevent viruses from infecting cells, although questions remain about how long antibodies against COVID-19 actually last and how much protection from infection they actually provide. The new serology test will help researchers study the virus’ neutralizing antibodies, noted Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” Stenzel noted in a statement. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but [the GenScript cPass test] authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus.”

The Test

The GenScript cPass test is a blocking enzyme-linked immunosorbent assay (ELISA) designed to mimic the virus’ neutralization process to detect total neutralizing antibodies to SARS-CoV-2 in human serum and plasma, with results provided in approximately one hour. The test does not require live virus, which enables it to be used in standard research or clinical diagnostic laboratories that do not have a biosafety level 3 rating.

In addition to detecting prior SARS-CoV-2 exposure and the presence of neutralizing antibodies in convalescent patients, GenScript said that the test is expected to help in the assessment of SARS-CoV-2 vaccine candidates where a standardized test that can detect neutralizing antibodies will be needed for large patient cohorts. It can also be used to screen animals for SARS-CoV-2 infection without modification.

Takeaway

The cPass test is authorized for use by any CLIA-certified laboratory to perform high-complexity tests, according to the FDA. The agency also clarified that testing positive for COVID-19 neutralizing antibodies does not necessarily mean that a patient is protected from COVID-19. So, patients and providers still need to follow public health precautions.


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