SINGAPORE: A rapid antibody test kit for COVID-19 that can be used to identify asymptomatic people and produces “accurate” results in 15 minutes has been developed and manufactured in Singapore.
The test kit, Assure, detects antibodies produced by the human immune system in response to exposure to SARS-CoV-2 – the virus that causes COVID-19 – said the two groups behind the product, diagnostic corporation MP Biomedicals Asia Pacific and the Agency for Science, Technology and Research (A*STAR) in a joint media release on Friday (Jul 24).
Assure SARS-CoV-2 IgG/IgM Rapid Test Kit. (Photo: MP Biomedicals)
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Specifically, the kit detects IgG and IgM antibodies produced by the body to combat SARS-CoV-2 from samples of human blood, plasma or serum.
“Studies have shown that levels of IgG and IgM appear to be correlated with the severity of COVID-19, thus they are good biomarkers for confirming positive or past infection,” according to the press release.
The kit uses “proprietary synthetic SARS-CoV-2 proteins” that bind to the IgG and IgM antibodies if they are present in the specimen samples, both groups said.
Assure uses a lateral flow format similar to those used in home pregnancy tests. (Image: MP Biomedicals Asia Pacific, A*STAR)
The rapid antibody test kit was evaluated by the National University Hospital’s (NUH) Department of Laboratory Medicine and “demonstrated good results for both serum and whole blood”.
“The sensitivity of the kit performed well as compared to commercial immunoassays, when tested with convalescent blood from recovered COVID-19 patients in the clinic,” MP Biomedicals Asia Pacific and A*STAR said.
This test kit will complement global efforts to develop more efficient diagnostics as the COVID-19 situation evolves, said Dr Sidney Yee, chief executive officer of DxD Hub at A*STAR.
“It is absolutely critical that we continue to transfer R&D know-how to biotech companies, to scale up and let more labs tap on this diagnostics test kit to screen patients,” Dr Yee said.
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LIMITATIONS OF THE RAPID ANTIBODY TEST KIT
While the test kit can help identify asymptomatic individuals or those with only mild symptoms who were not subjected to a specific type of polymerase chain reaction testing, it should not be used in the clinical diagnosis of COVID-19 infections.
“Aligned with the current recommendation by the World Health Organization, point-of-care or rapid serology tests including Assure rapid antibody test kit should not be used in the clinical diagnosis of COVID-19 infections or in the evaluation of persons with acute respiratory symptoms, especially within the first 14 days of illness,” said the press release.
“This is to avoid giving patients false reassurance that they do not have the infection, arising from a negative result.”
Scientists from A*STAR’s Institute of Molecular and Cell Biology (IMCB), led by Joint Senior Principal Investigator, Associate Professor Tan Yee Joo (left), inspecting antibody cell cultures. (Photo: A*STAR)
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Nonetheless, it can “help identify segments of (the) communities that are recovering from or previously infected by SARS-CoV-2 to ensure their safe return back to work”, added Mr Ng Boon Heong, the chief executive officer of Temasek Foundation which had piloted the use of the test kits in the local community.
The Assure rapid antibody test kit has been granted provisional authorisation by the Health Sciences Authority for its intended use in Singapore.
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