GenScript Obtains USA for SARS-CoV-2 Neutralizing Antibody Detection Kit

GenScript USA, a provider of research reagents, said the US FDA has granted Emergency Use Authorization (EUA) for the cPass SARS-CoV-2 Neutralizing Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live viruses. Neutralizing antibodies, a subset of antibodies that can specifically block the virus’s ability to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2.

The conventional method of measuring neutralizing antibodies requires that the tests be performed in a high security level (BSL3) facility staffed with specialized personnel. Live virus assay results are normally available over several days and due to the unpredictable nature of the live virus and the live cell reagents used, these tests are also difficult to standardize. Results from different installations may vary, even if performed using the same protocol. In contrast, the cPass kit uses pure proteins that can be produced in a more reproducible way.

Detection of the presence of neutralizing antibodies can also be performed in most standard clinical diagnostic or research laboratories with a short turnaround time (~ 1 hour), making it widely available and much more consistent between different facilities. . Furthermore, a direct clinical performance comparison between the conventional live virus and the cPass assay shows that the results of both tests are strongly correlated.

“Unlike commercially available antibody-based tests that are commonly used to detect previous exposure to the virus, the cPass kit can assess both previous exposure and the presence of neutralizing antibodies in convalescent patients,” said David Martz, Vice President of Management of new products in the Life Sciences Group at GenScript. “The cPass kit is also a valuable tool for evaluating vaccine performance. When vaccine companies begin phase II or III trials, a standardized test that can detect neutralizing antibodies will be needed for a large cohort of patients to assess efficacy. of vaccines in different populations and regions “.

“The cPass test can also be used to detect SARS-CoV-2 infection in animals without modification, as it works independently of the species,” added Professor Linfa Wang of the Emerging Infectious Diseases Program at Duke National University. from Singapore. Medical School, whose team pioneered the development of this novel testing platform.