Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance, notes the publication of the preliminary report of an independent evaluation of Abc-19TM by Ulster University.
The independent report compares three commercially available immunoassays to evaluate performance metrics for the AbC-19TM lateral flow test, which is developed by the UK-RTC. The report notes the lack of a well-accepted gold standard assay against which to measure any newly developed immunoassay designed to detect antibodies to SARS-CoV-2.
To overcome these challenges, a ‘pseudo gold standard’ system was established against which to analyse the sensitivity and specificity of each of the three commercially available immunoassays using a well-characterised serology sample set to evaluate performance metrics for the AbC-19TM test. Using the ‘pseudo gold standard’ system the report concludes that the UK-RTC AbC-19 lateral flow immunoassay shows a sensitivity of 97.70% (95.72%-99.34%) and specificity of 100% (100.00-100.00%).
A link to the preliminary report can be found here:
https://www.medrxiv.org/content/10.1101/2020.09.29.20201509v1
