SF COVID-19 2020-2022

Offentlig prosjektsammendrag

The test that the project partners, Norwegian SME Gentian AS and University i Tromsø (UiT)/Norwegian Arctic University will develop in this project, will consist of a turbidimetric immunoassay that detects antibodies towards SARS-CoV-2 in the human blood, giving information on if an individual has developed antibodies to the virus and the degree of immunity obtained (as the test gives quantitative results), even if the individual has been non-symptomatic. 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. An automated, turbidimetric assay that will be 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. 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). To the best of our knowledge, there are no other turbidimetric tests available to detect SARS-CoV-2 antibodies.