Another Breakthrough in Epidemic Prevention!

Another Breakthrough in Epidemic Prevention! The Team at Kaohsiung Medical University Has Developed a COVID-19 Antibody Testing Platform for Precise Assessment of Antibody Efficacy

In the ongoing global battle against the evolving pandemic and heightened individual protective measures, Taiwan's biotechnology sector has achieved a significant milestone in epidemic prevention. Professor Sheng-Fan Wang's team from the Department of Medical Laboratory Science and Biotechnology, College of Health Sciences at Kaohsiung Medical University (referred to as KMU), has successfully developed two COVID-19 antibody testing technologies with the support of the Ministry of Science and Technology. These innovations include the SARS-CoV-2 Spike IgM/IgG ELISA, which tests blood samples, and the Spike Antibody ELISA Neutralization Assay platform. These methods enable precise, effective, and rapid testing of patients' serum samples after a recovery period of more than 14 days, as well as evaluation of antibody efficacy in individuals who have received both vaccine doses. Within 1.5 hours, the platform can determine the autoantibody efficacy and neutralizing protection against COVID-19, including the Delta variant, with an accuracy of over 95%. This provides the latest tool for population-level immunity assessment and individual epidemic prevention, addressing the continuously evolving global situation. It also prepares for post-epidemic recovery, border reopening, and international travel.

Professor Sheng-Fan Wang pointed out that the antibody efficacy assessments of both testing methods are consistent with the results of the FDA-authorized Abbott assays (with specificities and sensitivities ranging from 98 to 100%). Furthermore, the assessment of the Spike antibody ELISA neutralization assay on the testing platform revealed a high degree of consistency with the results obtained using the SARS-CoV-2 Pseudovirus system (a pseudo-virus system of this virus with the same outer membrane protein as the actual SARS-CoV-2 virus has been confirmed for use in neutralization tests), with a specificity of 100% and sensitivity ranging from 96% to 99%. The precision of these results has greatly energized the team.

In late November, Taiwan's COVID-19 vaccination coverage for the first dose exceeded 75%, and the coverage for the second dose reached 50%. As the country moves towards reopening, a new wave of the pandemic has emerged in Europe and the United States. A new variant of the coronavirus, discovered in South Africa, has been officially named Omicron by the World Health Organization. It is even more contagious than the Delta variant, leading to travel restrictions and lockdowns in several countries. In addition to planning for third-dose vaccinations in many nations, there is a growing focus on strengthening herd immunity and individual protection.

Regarding the convenience and accuracy of the testing methods, Professor Wang further pointed out that these two testing platforms require only a small amount of serum sample (approximately 5 microliters, 0.005 milliliters) for testing, and results can be obtained within 1.5 hours. He stated that the detection platform based on the principles of Enzyme-linked immunosorbent assay (ELISA) is convenient, rapid, cost-effective, and offers high sensitivity and specificity. It is widely used in the majority of clinical laboratories for conducting tests related to pathogen antigens and antibodies. Currently, the widespread transmission of the novel coronavirus in the population has led to the continuous evolution of many variants of the virus. Research has shown that some variants of the novel coronavirus increase their binding affinity with ACE2 receptors, promoting infection rates. Mutations in the Spike protein also reduce the efficacy of COVID-19 vaccines.

Furthermore, the concentration of antibodies in the body after receiving two doses of COVID-19 vaccine, the duration of antibody persistence, and the protective efficacy of antibodies against variant strains all require continuous monitoring. Multiple international Real World Evidence (RWE) studies have indicated that in most COVID-19 vaccine recipients, antibody concentrations significantly decrease after 6–8 months of vaccination, and even in some cases, antibodies cannot be detected. Therefore, the World Health Organization and the U.S. Food and Drug Administration are currently formulating guidelines for administering a third vaccine dose. In response, the academic and industry sectors are actively developing assays and platforms capable of measuring antibody efficacy after vaccination and assessing the antibodies' ability to neutralize the virus.

The COVID-19 research team at KMU recently achieved significant results in antibody testing for vaccines: the SARS-CoV-2 Spike IgM/IgG ELISA and the Spike Antibody ELISA neutralization assay platform. These can be used to assess the antibody efficacy in patients with the novel coronavirus and in individuals who have received the COVID-19 vaccine and understand the neutralizing and protective capabilities of antibodies against different variants of the novel coronavirus, including Alpha, Beta, Delta, and other SARS-CoV-2 variants. Both testing methods have undergone field verification at the affiliated Kaohsiung Medical University Chung-Ho Memorial Hospital, and the verification results are consistent with those of multiple international research institutions, highlighting the remarkable achievements of the KMU medical team.

Currently, KMU continues its industry–academia collaboration with AMS BioteQ, and soon they plan to transfer the technology of the SARS-CoV-2 Spike Antigen Rapid Screening Test developed by KMU to AMS BioteQ. They hope that this product can be utilized in COVID-19 airport screenings and home rapid testing, joining forces to combat the threat of the novel coronavirus invasion!