May is a consultant for Roche Diagnostics.. unfavorable percent agreement (NPA) were calculated. Antibody concentrations were compared across the platforms and populations. Results A total of 588 remnant samples derived from 500 patients were tested. PPA at 5C12 weeks post-PCR positive results for Assays A-D was 98.3, 97.4, 99.2, and 95.8% respectively. NPA was 100% across all platforms. Mean antibody concentrations at 2C4 weeks post-PCR positive result were significantly higher in hospitalized versus non-hospitalized patients, respectively, for Assay A (131.8 [101.7] vs. 95.6 [100.3] AU/mL, P?Erythrosin B emergency use authorization (EUA) [5]. Of these 502, 85 are serology assessments. These serology assays target either total antibodies (IgA, IgM, IgG), IgM/IgG, or IgG against either the SARS-CoV-2 nucleocapsid (N) or spike (S) proteins. Early serology assays were qualitative, with newer assays exhibiting linear performance for semi-quantitative or quantitative measurements C raising the possibility of evaluating antibody titers among individuals experiencing vaccine breakthrough infections and determining the need for vaccine booster shots [6,7]. Unfortunately, the sheer diversity of EUA serology methodologies and lack of standardization creates significant challenges for healthcare professionals Rabbit Polyclonal to ZEB2 [8,9]. Comparative studies are needed to aid clinical laboratories and infectious disease experts to determine which assays may better suited to address evolving pandemic demands. To this end, the objective of our study was to evaluate the clinical performance of EUA serology assays in vaccinated and previously infected non-vaccinated patients. 2.?Methods We conducted a pragmatic observational study evaluating commercial EUA laboratory-based COVID-19 serology assays available at our institution. Remnant serum samples from 500 adult (age 18 years) patients were aliquoted and frozen at ?70?C for batched serology testing. Samples were stored in our institution’s College of American Pathologists (CAP) accredited biorepository. Patient demographics (age and gender), vaccination status, number and timing vaccine dose, and number of days post molecular COVID-19 result. COVID-19 vaccines available at the time of the study were mRNA based (Pfizer Erythrosin B and Moderna) and require at least two doses to achieve maximum efficacy [10]. Molecular testing was performed as part of routine clinical evaluation of patients using EUA reverse transcription polymerase chain reaction (RT-PCR) SARS-CoV-2 assays. At our institution, two EUA RT-PCR assays were employed to support routine patient care needs: (a) laboratory-based high throughput batched testing platform (Cobas 6800, Roche Molecular Systems, Pleasanton, CA), and (b), a rapid point-of-care (POC) testing platform (Cobas Liat, Roche Molecular Systems, Pleasanton, CA). The high throughput RT-PCR platform targets the open reading frame (ORF) 1a/1b, and the envelope (E) protein regions within the SARS-CoV-2 genome. In contrast, the POC assay targets ORF1a/1b and N protein genes [11]. Four EUA laboratory-based serology assays.
