Brazil’s National Health Surveillance Agency (ANVISA) has authorized the use of the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, from GenScript USA, Piscataway, NJ, for detecting neutralizing antibodies. The cPass test is the first and only ANVISA-authorized test for detecting neutralizing antibodies to SARS-CoV-2. Neutralizing antibodies specifically block the ability of a virus to infect a cell and are well-recognized to confer immunity.
Authorization for use of cPass in Brazil follows FDA emergency use authorization of the test in November and provisional use in Singapore earlier this year. The kit has also been granted a CE Mark in Europe. It is the only neutralizing antibody test to have obtained all of these authorizations by regulatory authorities.
“We’re extremely pleased to receive emergency use authorization in Brazil and look forward to rapidly distributing it to labs, healthcare institutions, and pharmaceutical firms across the country,” says David Martz, vice president of new product management in Life Science Group at GenScript, “Because the cPass kit detects the specific antibodies that block the virus, it’s a particularly valuable tool for monitoring patients for virus-blocking antibodies after they have recovered from COVID-19, as well as for determining the duration of vaccine protection post immunization.”
The cPass kit is also the first and only ANVISA- and EUA-authorized test to specifically detect neutralizing (virus blocking) antibodies in patient samples without the use of live virus. The conventional method to measure neutralizing antibodies in the patient samples requires the use of live cells and obtaining results takes multiple days in very controlled, high safety environment (BSL3). In contrast, the cPass kit is an ELISA assay and can be performed in most standard laboratories with short turnaround time, of about 1 hour.
The cPass kit is being distributed in Brazil by NL Diagnostica, Sao Paulo.
For more information, visit GenScript USA.