Genscript Biotech Europe has received CE-IVD for its neutralising antibody test kit of SARS-CoV-2 diagnostic products to be sold as an in vitro diagnostic (IVD).
The products include cPass SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit, which detects the presence of neutralising antibodies in an hour without requiring live biological materials or biosafety containment for testing.
The company noted that the test is a major advance in understanding the epidemiology of the disease and if individuals have developed neutralising antibodies that may confer immunity.
GenScript Biotech Europe president Patrick Liu said: “Acquiring the CE-IVD mark expands the market opportunity for our detection kits in the EU and other major international markets.
“I hope cPass Test Kit will play a critical role in the global efforts of overcoming the pandemic.”
The test was co-developed by Duke-NUS Medical School, GenScript Biotech Corporation and Singapore’s Agency for Science, Technology and Research (A*STAR).
Duke-NUS Medical School Emerging Infectious Diseases programme director Dr Wang Linfa said: “The cPass Test Kit can be used for contact tracing, reservoir or intermediate animal tracking, assessment of herd immunity, the longevity of protective immunity and efficacy of different vaccine candidates.
“It does not require a biosafety containment facility, which makes it immediately accessible to the global community, including many developing nations.”
GenScript also offers qRT-PCR detection kits and IgG & IgM serological testing kits.
The tests together with other CE-IVD tests are said to deliver complete infection history of a person, from initial infection to the point of monitoring neutralising antibodies as an indicator of future immunity against the virus, the company said.