cPass™ SARS-CoV-2
Neutralization Antibody Detection Kit (CE)

GenScript cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit, also known as SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit, is faster, easier, more scalable and automatable alternative to the traditional neutralizing antibody tests, such as virus neutralization test (VNT), pseudo-virus neutralization test (pVNT) and plaque reduction neutralization test (PRNT). The kit has the capability of measuring functional neutralizing antibodies (NAbs) within an hour instead of the days required by the traditional tests. cPass Neutralization Antibody detection kit does not require live biological materials or strict biosafety containment for testing (i.e. BSL3 containment). All aspects of the quality management system are certified to ISO 13485. GenScript has acquired CE mark (Europe) and HSA provisional approval (Singapore) and has been issued Emergency Use Authorization (EUA) by U.S. FDA.

A new coronavirus, SARS-CoV-2, has recently emerged to cause a human pandemic. There is an urgent need for a robust serological test to detect neutralizing antibodies to SARS-CoV-2. Validated serologic assays are important for contact tracing, identifying the viral reservoir and epidemiological studies.

There are two types of antibody tests that aim for detecting COVID-19 infection with sufficient specificity and sensitivity. The first type is the virus neutralization test (VNT) which detects neutralizing antibodies (NAbs) in a patient's blood. VNT requires handling live SARS-CoV-2 in a specialized biosafety level 3 (BSL3) containment facility which is tedious and time consuming, taking 2-4 days to complete. Pseudovirus-based virus neutralization test (pVNT) is similar, but still requires the use of live viruses and cells although handled in a BSL2 laboratory.

All other assays, such as ELISA and lateral flow rapid tests, represent the second assay type which detect only binding antibodies, and not Nab.

Professor Lin-Fa Wang's lab at Duke-NUS Medical School established a Surrogate virus neutralization test (sVNT) which detects NAbs, but without the need to use any live virus or cells and can be completed in 1-2 hours in a BSL2 lab. Using purified receptor binding domain (RBD) protein from the viral spike (S) protein and the host cell receptor ACE2, the test is designed to mimic the virus-host interaction by direct protein-protein interaction in a test tube or an ELISA plate well. This highly specific interaction can then be neutralized, i.e., blocked by highly specific Nabs in patient or animal sera in the same manner as in a conventional VNT.

Table 1:The kit has been evaluated in China, Singapore, and USA. Here's the data summary.

Table 2: Data grouped by days.