A New COVID-19 Antibody Test Developed by Singaporean Biomedical Firm

It works by employing an Enzyme-linked immunosorbent assay that captures and detects the antibodies specific to the COVID-19 nucleocapsid protein.

Singapore biomedical firm Restalyst has developed a COVID-19 antibody test, which will be instrumental in establishing disease prevalence in populations and the exposure risk factors associated with infection. This will enable healthcare authorities to determine the effectiveness of COVID-19 control measures and to streamline them in the long run. Insights into population segments more susceptible to infection will also aid the future roll-out of vaccines.

The need for serology tests has increased, particularly in detecting prior infections in asymptomatic patients. COVID-19 infections are diagnosed through real-time reverse transcription-polymerase chain reaction (RT-PCR), performed using a nasopharyngeal swab. It confirms the presence of the virus. RT-PCR cannot be used for assessing disease prevalence, as a negative result cannot differentiate a person who was previously infected and has since recovered, from an infected person. Unlike RT-PCR, COVID19N-REAAD™ homes in on an adaptive immune response to COVID-19, indicating recent or prior infection. It works by employing an Enzyme-linked immunosorbent assay that captures and detects the antibodies specific to the COVID-19 nucleocapsid protein.

"Serology tests like COVID19N-REAAD™ aid in the investigation of ongoing epidemics, and in the retrospective assessment of infection rates and the extent of an outbreak. They are invaluable in determining the full scope of the disease, and are vital in enabling a coordinated and effective national-level outbreak response," said Zaccheus Peh, CEO of Restalyst.

A study using 387 clinical samples -- comprising 56 RT-PCR positive and 331 healthy cohorts for COVID-19 -- found that COVID19N-REAAD™ has an estimated clinical sensitivity and specificity of 98.21% and 100% respectively. The test was validated through comparative studies with Siemens ADVIA Centaur® SARS-CoV-2 Total and Roche Elecsys Anti-SARS-CoV-2 which are FDA approved serological tests. The studies were conducted using 132 serological reactive and 267 serological non-reactive samples as determined by the two assays. It was found that COVID19N-REAAD™ had a positive percent agreement, a negative percent agreement, and the overall rate of agreement of 97.73%, 91.01%, and 93.23% respectively.

COVID19N-REAAD™ has received both the CE mark and provisional authorization by the Singapore Health Sciences Authority.

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