World’s First SARS-CoV-2 Serology Test Detects Neutralizing Antibodies Without Containment Facility or Specimen

Researchers have developed the world’s first serological coronavirus detection system that allows for rapid detection of neutralizing antibodies (NAbs) present in the serum of COVID-19 patients without the need for live biological materials and biocontainment facility.

GenScript Biotech Corporation (Piscataway, NJ, USA), Duke-NUS Medical School, and the Diagnostics Development Hub (DxD) at Singapore’s Agency for Science, Technology and Research (A*STAR) have entered into an exclusive agreement to co-develop and manufacture the unique serological COVID-19 detection system known as the surrogate virus neutralisation test (sVNT) or cPass.

cPass is the world’s first COVID-19 lab-based antibody test kits that is capable of measuring functional NAbs. Without a simple test kit, measuring NAbs requires the use of live virus, cells, highly skilled operators, and complex laboratory procedures that are generally less sensitive and require several days to obtain results. In contrast, cPass can be rapidly conducted within an hour in most research or clinical labs, and is also amenable to high throughput and fully automated testing after minimal adaptation. The test will also help in current COVID-19 investigations, from contact tracing to determining infection rates, herd immunity and predicted humoral protection.

Professor Wang Linfa, Director of Duke-NUS’ Emerging Infectious Diseases programme, and team conceived this research and invented the cPass diagnostic test. The team also did the assay development and testing in Singapore. GenScript went through the steps of proof concept research, product design, development and optimization, and now plays a central role in the commercialization process, using its global network and manufacturing capacity to launch cPass in Singapore and other regions around the world. DxD Hub validated the kit with clinical samples, and developed the manufacturing protocol and quality controls to secure its provisional authorization by the Health Sciences Authority. DxD Hub will also be producing the pilot batch for use in Singapore hospitals. There are plans for this know-how to be transferred to local biotech companies for scaled-up production.

“The cPass developed by our team can be used for contact tracing, reservoir or intermediate animal tracking, assessment of herd immunity, 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,” said Professor Wang Linfa, the principal investigator of this collaboration.

“The serological detection system developed by Prof Wang is unique, innovative, and has many advantages, such as high sensitivity and specificity, and applicability to all antibody isotypes,” said Dr. Zhu Li, Chief Strategy Officer of GenScript. “The test results will be of great help to governments in guiding the resumption of work since it is extremely useful for quick and reliable surveillance to determine how widely a population has gained immunity to SARS-CoV-2 virus. Detection of neutralising antibodies determines who can more safely go back to work or to more social life. Our partnership with Duke-NUS and DxD Hub is one of several proactive steps we are taking to strengthen our R&D and manufacturing capacity to meet this urgent global need.”

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