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Development of Rapid Antibody Point-Of-Care Test Kit for SARS-CoV-2

MP Biomedicals Asia Pacific Pte Ltd and the Agency for Science, Technology and Research (A*STAR) co-develop a rapid antibody test kit that is able to produce accurate results within 15 minutes.

Announced in late July 2020, global diagnostic corporation, MP Biomedicals Asia Pacific Pte Ltd together with A*STAR have successfully developed a rapid antibody test kit for COVID-19. The kit, ASSURE® SARS-CoV-2 IgG/IgM rapid test, or ASSURE® in short, detects antibodies produced by the human immune system in response to SARS-CoV-2.

The ASSURE test kit detects antibodies IgG and IgM from samples of human blood, plasma or serum. Levels of these two antibodies have been shown in previous studies to be correlated to the severity of COVID-19 in the patient. However, in line with current recommendations by the World Health Organisation, such point-of-care tests kits should not be used for clinical diagnosis of COVID-19 or in the evaluation of persons with acute respiratory symptoms, especially within the first 14 days of illness. This is particularly to avoid false negative results.

This antibody test kit therefore assists in determining whether an individual has been previously exposed to the virus resulting in the production of antibodies against it. Through the rapid test, asymptomatic individuals or those with mild symptoms can be identified.

The technology behind the ASSURE® rapid antibody test kit utilises proprietary synthetic SARS-CoV-2 proteins. These proteins bind to the IgG and IgM antibodies if the antibodies are present in the specimen samples.

The kit employs a lateral flow format similar to those used in home pregnancy tests which was developed by MP Biomedicals’ lateral flow platform. The Diagnostics Development (DxD) Hub, a national platform hosted by A*STAR’s commercialisation arm, A*ccelerate, co-developed the validation protocols and quality controls.

The ASSURE® 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.

“The development and manufacture of ASSURE® is a successful collaboration between MP Biomedicals and A*STAR through tremendous joint work. We are not the first one in the market but chasing the best performance is always our primary goal. With this rapid antibody test kit, we are proud to contribute to the global fight against COVID-19.” Shared Dr Delynn Xu, Senior R&D Manager, MP Biomedicals.

The rapid antibody test kit has been granted Provisional Authorisation by the Health Sciences Authority (HSA) for its intended use in Singapore. ASSURE® was developed and manufactured in Singapore to be deployed for point-of-care testing. It has since been distributed to other regions such as Europe, Africa and South America. Further to this, MP Biomedicals is preparing for application of Emergency Use Authorization (EUA) from the United States FDA.

Dr Sidney Yee, Chief Executive Officer, DxD Hub, A*STAR, said: “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. This rapid serological point-of-care test kit for COVID-19 by MP Biomedicals and A*STAR will complement global efforts to develop more efficient diagnostics, as the COVID-19 situation continues to evolve.” [APBN]