MP Biomedicals and A * STAR jointly develop rapid antibody test kit for COVID-19

July 25, 2020

MP Biomedicals Asia Pacific Pte Ltd has been in the business for over 30 years focusing on the development and manufacturing of various infectious disease tests, and today, in collaboration with the agency, is developing a rapid antibody test kit for COVID-19. Announced success. Science, technology, research (A * STAR).

MP Biomedicals Diagnostics R&D Team and ASSURE (R) SARS-CoV-2 IgG / IgM Rapid Test Kit. The two devices shown reflect a positive IgG antibody result (marked right side) and a negative measurement (unmarked left side). From left: Ivy Teoh. Delynn Xu; Zee Hong Goh (Photo credit: MP Biomedicals)

Named ASSURE^® SARS-CoV-2 IgG / IgM rapid test, or ASSURE^® In essence, this test kit detects antibodies produced by the human immune system in response to exposure to SARS-CoV-2. It gives accurate results in just 15 minutes and uses a lateral flow format similar to that used in home pregnancy tests. Guarantee^® Developed and manufactured in Singapore. It can be located at or near the point of patient care and is distributed throughout Europe, Africa, South America and other regions. MP Biomedicals will also apply for an Emergency Use Authorization (EUA) from the US FDA for this product.

The test kit detects IgG and IgM antibodies produced in the body to counter SARS-CoV-2 in human blood, plasma, or serum samples. Studies show that IgG and IgM levels appear to correlate with COVID-19 severity and are excellent biomarkers for confirming positive or past infections.

Rapid serum testing including current World Health Organization recommendations, point of care, or ASSURE^® Do not use the rapid antibody test kit within the clinical diagnosis of COVID-19 infection or evaluation of people with acute respiratory symptoms, especially within the first 14 days of illness. This is to avoid giving the patient false reassurance that the patient is not infected due to negative consequences. However, ASSURE^® A rapid antibody test kit can help determine if an individual has been previously exposed to the virus and consequently produced antibodies. This helps identify asymptomatic individuals or individuals with only mild symptoms who have not undergone RT-PCR testing.

The technology behind ASSURE^® The rapid antibody test kit utilizes a unique synthetic SARS-CoV-2 protein. These proteins bind IgG and IgM antibodies when antibodies are present in the analyte sample. MP Biomedicals used it to develop products based on lateral flow platforms. The Diagnostic Development (DxD) Hub is a national platform hosted by A * STAR’s commercialization division, A * ccelerate, which has jointly developed a validation protocol and quality control. relief^® The High Speed ​​Antibody Test Kit was evaluated by the National University Hospital (NUH) Department of Laboratory Medicine and showed good results for both serum and whole blood. When tested with convalescent blood from COVID-19 patients collected at the clinic, the sensitivity of the kit performed well compared to commercial immunoassays.

relief^® The Rapid Antibody Test Kit has been provisionally approved by the Health Sciences Authority (HSA) for use in Singapore.

Development and manufacturing of ASSURE^® A successful collaboration through the tremendous collaboration between MP Biomedicals and A* STAR. We are not the first on the market, but chasing the best performance is always our main goal. We are proud to contribute to the global battle against COVID-19 with this rapid antibody test kit. “

Dr. Delynn Xu, Senior R&D Manager, MP Biomedicals

“We identified a human monoclonal antibody that binds to SARS-CoV-2 and found it useful in the early stages of the development of this rapid test kit,” said Associate Professor Tanyege, Chief Principal Investigator at the Molecular Research Institute. I am. Department of Cell Biology (IMCB), A* STAR, and Yong Loo Lin School of Medicine, National University of Singapore. “IMCB is pleased to be able to help industry partners develop COVID-19 products,” she added.

It is imperative that R&D know-how be continuously transferred to biotechnology companies and scaled up so that more and more laboratories utilize this diagnostic test kit to screen patients. This rapid serum point-of-care test kit for COVID-19 by MP Biomedicals and A* STAR complements the global effort to develop more efficient diagnoses as the COVID-19 situation continues to evolve. I will. “

Dr. Sydney Yi, A* STAR, DxD Hub, CEO

Ng Boon Heong, CEO of Temasek Foundation, said: Medical partners such as A* STAR. Developed by medical partners such as NUH to provide access to point-of-care rapid serology kits. These kits help identify and safely protect segments of communities that are recovering or previously infected with SARS-CoV-2. I’ll get back to work. This is one of the first efforts by MP Biomedicals to help expand production locally and piloting its use in our community. “