Home » US FDA authorises use of serology test kit developed by Singapore

US FDA authorises use of serology test kit developed by Singapore

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In a first for Singapore, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.

These are antibodies that bind to a specific part of a pathogen. They have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.

Called cPass, this smart rapid test kit is developed by DUKE-NUS Medical School together with GenScript Biotech Corporation and A*Star’s Diagnostic Development Hub (DxD).

The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit in a media release on 6 November.

cPass Smart Rapid Test Kit; First in the world

Photo Credit: Duke-NUS Medical School

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.

Professor Wang Linfa, Director of the Duke-NUS’ Emerging Infectious Diseases programme, and team conceived this research and invented the cPassTM 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. It now plays a central role in the commercialisation process, using its global network and manufacturing capacity to launch cPassTM in Singapore and other regions around the world.

A*STAR’s 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.

Useful for contact tracing, assessing the efficacy of different vaccine candidates

Photo Credit: Duke-NUS Medical School

Prof Wang Linfa, the principal investigator said, “The cPassTM developed by our team 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. ”

Dr Zhu Li, Chief Strategy Officer of GenScript added, “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. 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.”

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