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18th May 2020  Content supplied by: GenScript USA Inc.

First-In-The-World SARS-CoV-2 Serology Test to Detect Neutralizing Antibodies

Duke-NUS Medical School, GenScript Biotech Corporation and the Diagnostics Development Hub (DxD) at Singapore's Agency for Science, Technology and Research (A*STAR), has announced an exclusive agreement to co-develop and manufacture a unique serological coronavirus (COVID-19) detection system known as the surrogate virus neutralisation test (sVNT) or cPass™.

This test is the first in the world that allows rapid detection of neutralising antibodies (NAbs) - the specific antibodies present in the serum of COVID-19 patients that are responsible for clearing the viral infection, without the need of live biological materials and biocontainment facility.

While there are many COVID-19 lab-based antibody test kits commercially available, this is the first that is capable of measuring functional NAbs. Without a simple test kit, measuring NAbs requires the use of a live virus, cells, highly skilled operators, and complex laboratory procedures that are generally less sensitive and require several days to obtain results.

By contrast, the 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. This 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 optimisation, and now plays a central role in the commercialisation process, using its global network and manufacturing capacity to launch cPass™ in Singapore and other regions around the world.

DxD Hub is a national initiative led by A*STAR's commercialisation arm, A*ccelerate. To take this sVNT to market, DxD Hub validated the kit with clinical samples and developed the manufacturing protocol and quality controls to secure its provisional authorisation 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.

It is claimed to have high sensitivity and specificity, and applicability to all antibody isotypes that provide immunity. 

The cPass™ assay was validated with samples of patients from PROTECT- A Multi-centred Prospective Study to Detect Novel Pathogens and Characterise Emerging Infections, coordinated by Singapore's National Centre for Infectious Diseases.

VIDEO: Professor Wang Linfa, director of Duke-NUS, ' talks about why a kit that can detect neutralizing antibodies is of utmost importance to stop the spread of SARS-CoV-2.

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Date Published: 18th May 2020

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