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

This first of its kind test allows rapid detection of neutralizing 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.

Professor Wang Linfa, Director of the 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.

The cPass assay was validated with samples of patients from PROTECT- A Multi-centered Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections, coordinated by Singapore’s National Centre for Infectious Diseases (NCID). 

WHY IT MATTERS

Although there are many commercially available COVID-19 lab-based antibody test kits in the market such as Biolidics’ COVID-19 rapid test kit and Camtech Diagnostics’ COVID-19 IgG/IgM Rapid Qualitative Screening Test, the newly released test is the first 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. Moreover, 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.

UPCOMING DEVELOPMENTS

To take this sVNT to market, DxD Hub validated the kit with clinical samples, developed the manufacturing protocols and quality control processes, and secured its provisional authorization by the Health Sciences Authority (HSA). 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 LARGER TREND

With the continually growing number of COVID-19 infections worldwide, governments and health authorities are finding ways to increase testing and there has been a global demand for COVID-19 test kits. In the UK, Imperial College London and Intelligent Fingerprinting have joined forces to develop a simple 10-minute COVID-19 fingerprint test, MobiHealthNews reported.

Dutch biotech startup ViroTact has recently secured funding for its portable test that can detect COVID-19 within 30 seconds. In the US, companies like Hims & Hers and Vault Health now sell FDA-authorized home COVID-19 tests via telehealth.

ON THE RECORD

“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.

Sherry Shao, President of Life Science Group at GenScript added, “The collaboration with Duke-NUS is a key example of how global industry and academia work together to make things happen. Leveraging the leading technologies in molecular biology, protein science and immunology, we help our partners in virus mapping, detection, treatment and vaccine development. GenScript is committed to fighting the pandemic with the world.”

Dr Sidney Yee, CEO of DxD Hub said: “As Singapore’s national platform that provides end-to-end expertise in bringing diagnostic kits from bench to bedside, DxD Hub is proud to be part of this collaboration with Duke-NUS and GenScript. This innovative cPass diagnostic kit will be instrumental in supporting the fight against the global pandemic.”