Development of a novel high-throughput Sars-CoV-2 antibody test

Norwegian Gentian AS and University i Tromsø (UiT)/Norwegian Arctic University are working together to develop a high-throughput COVID-19 antibody test. The test detects antibodies towards SARS-CoV-2 in the human blood, giving quantitative information on the degree of immunity obtained, even if the individual has been non-symptomatic. The test was launched in 2022. State-of-the-art methods for testing antibodies are point of care (mainly lateral flow) or heterogenous multi-step analysis on large automated analyzers (immunochemical, ELISA, etc). However, these technologies have drawbacks such as high-cost, low throughput (tests per hour) or can only work only on closed, proprietary systems. With Gentians technology there is an opportunity to significantly increase testing capacity and make testing available and affordable to all. The assay will be designed for use on clinical analysers already available in major laboratories around the world. Testing on clinical analysers allows for fast, cost-effective, high throughput (up to 2000 tests/hour) testing. There are over 430000 different platforms (clinical chemistry instruments using turbidimetry) at central clinical laboratories worldwide. The test will have near 100% sensitivity (the ability of a test to correctly identify those with the disease or true positive rate), and specificity (ability to correctly identify those without the disease or true negative rate). Gentian SARS-CoV-2 Total Antibody Assay is a valuable tool to: - Provide tool for the long-term surveillance of immunity of the society - Guide educated decisions about herd immunity and vaccination strategy - Documented protection? possibility for the population and for all Norwegian businesses including tourism/travel

OUTCOMES (virkninger) The partners have gained knowledge and expertise on the development of antibody tests, that can be used in future products (for example for a next pandemic or in case of a SARS-CoV-2 mutation). We have also gained knowledge on "fast track" development. IMPACT (effekter) An automated, turbidimetric assay developed in this project is fast, cost-effective, and allows for a high throughput (up to 2000 tests/hour) testing of samples. Turbidimetric detection of biomarkers intended for use in any platform available on the market. There are over 430’000 different platforms (clinical chemistry instruments using turbidimetry) at central clinical laboratories worldwide. Our test will, therefore, be a valuable tool for 1) the SARS-CoV-2 immune status screening of the population, 2) identify donors of convalescent plasma/serum used in treatment of seriously ill COVID-19 patients; 3) complementing PCR-based diagnosis; and 4) measure and monitor vaccine response.

Primary objective The project partners will develop and bring to market a robust, particle-enhanced immunoassay for use on open platform clinical analyzers which detects antibodies towards SARS-CoV-2 in the human blood and/or saliva with sensitivity and specificity near 100%, and which quantitative results are informative of (the degree of) immunity obtained. Secondary objectives - Investigate the highest quality viral antigen (developing or selecting) with strong properties towards SARS-CoV-2 specific antibodies - Obtain near 100% sensitivity and specificity - Develop a coating process that will lead to binding a high amount of specific SARS-CoV-2 antibodies - Gaining more knowledge on SARS-CoV-2 properties, especially binding properties, and effects of those properties on the assay - Develop stable reagents - Establish clinical use of the test