A-235 Results and Interpretation: Serology Testing Platforms and Assays Compatibility Assessment for MASTM SARS-CoV-2 IgG Quality Controls

Abstract Background Serology testing of antibodies against SARS-CoV-2 viruses serves many purposes: disease diagnosis, on-going and surveillance, epidemiologic vaccine studies, etc. There was a critical need to provide standardized quality control materials for development harmonization across different test methods IVD platforms. The MAS™ IgG Controls are human plasma-based containing SARS-CoV-2. offers commutability by mimicking patient samples is intended be used monitoring serological assays, providing confidence in routine results, troubleshooting system errors identification. We report here the compatibility assessment on assays Methods platforms assessed Positive Negative all 11 listed as below. These serology target either total (IgA, IgM, IgG), IgM/IgG, or nucleocapsid (N), RBD spike (S) proteins. Replicated were tested each instrument statistical confidence. Results All results demonstrated conclusively comparable performance controls clinical diagnostic manufactured Abbott, Roche, Ortho, DiaSorin, Beckman Coulter bioMérieux. positive showed 100% expected reactive (IgG Positive) at 82% non-reactive respectively. Furthermore, both compatible towards detecting targeting specific regions (N, S RBD). Conclusion remains unstandardized with numerous receiving FDA EUA. While multiple commonly platforms, found platform agnostic. To conclude, MAS will contribute assay offerings, monitor laboratory analytical performance, streamline workflow method development, validation verification, assessment.