ZTA Biotech, a Budapest-based biotech start-up has announced the breakthrough development of a COVID-19 antibody (IgG) test using the ELISA protocol.
This new detection method can determine if patients have had COVID-19 and if they might still have immunity to the disease. Early results have proven 100% in specificity after testing 280 samples, and 100% sensitivity by testing 260 samples of recovered and symptomatic patients.
ZTA Biotech is currently offering the intellectual property rights to licensees and/or to a sole-rights purchaser, in order to help bring this breakthrough ELISA formula to market. Given the relatively small number of ELISA-based protocols when compared to the global demand, the sale offers an opportunity in combatting the COVID-19 pandemic, since it gives a greater detail into the prevalence of the disease.
The presented ELISA (Enzyme Linked Immunosorbent Assay) protocol is designed for the intended use in the post-vaccination period that is soon to commence (first/second trimester of 2021). Its microplates are coated with critical antigens which are the prime targets of the current vaccine developments (of any kind). The kit can also be used to monitor past, natural exposure to SARS-CoV-2 and to evaluate the possibility of re-infection.
The test is based on selective detection of human IgG antibodies that bind to SARS- CoV-2 antigens coated on the wells of the microplate and can be used for qualitative and semi-quantitative determination of human IgG. After the completion of the first critical reaction step, all unbound serum components are fully washed away, and a series of reactions occur that will lead to a photometrically measurable step where the intensity of the obtained colour is proportional to the quantity of SARS-CoV-2 IgG antibodies in the original sample. The whole process takes less than two hours to complete and can be fully automated, and can be converted to a quantitative test, if needed.
The test was independently validated, with a sensitivity of 100% and a specificity of 100% and compared to an approved test of a major test producer, the latter being outperformed. All testing for validation was carried out on samples collected between September 2019 – June 2020. The antibody test showed extremely low background noise, and technical data is available upon request. All sensitivity evaluation data was based on PCR tested, positive SARS-CoV-2 patients, all symptomatic after getting infected. No cross-reactivity was observed to SARS- CoV-2 IgM. The kit is stable, has a long shelf life and opened kits are usable up to three months at storing temperatures of 5°C.
The test can also be adapted to potential virus mutations, based on sequencing data.
