Does Point-Of-Care SARS-CoV-2 Antibody Testing Have Similar Sensitivity and Specificity To High Complexity Serology?

O'Shea, Kelly; Schuler, Charles; Chen, Jesse; Gherasim, Carmen; Giacherio, Donald; Baldwin, James; Baker, James

Rationale: Point-of-care (POC) antibody screening for SARS-CoV-2 infection has yielded varied results. We analyzed two POC antibody testing devices to study whether these are comparable to ELISA testing done in a high complexity CLIA facility employed as a standard. Methods: We enrolled 146 individuals, with 41 individuals having had a history of positive PCR for COVID-19. After informed consent, we obtained serum and at the same time performed a finger stick for whole blood. Autobio and MEDsan rapid IgG/IgM tests that use SARS-CoV-2 spike protein to detect antibody were performed with serum and compared to Roche’s SARS-CoV-2 immunoassay, which uses nucleocapsid protein to detect antibody. The Autobio test was also evaluated using whole blood obtained by finger stick. Results: Serum testing using the Autobio kit versus the Roche immunoassay (used as the standard for comparison) revealed a sensitivity of 93.2% and a specificity of 96.1%;whole blood testing using the Autobio kit vs. the Roche immunoassay revealed a sensitivity of 90.5% and a specificity of 97.9%. Whole blood compared to serum testing using the Autobio POC kit revealed a sensitivity of 90.7% and a specificity of 99.0%. Serum testing using the MEDsan kit vs. the Roche immunoassay revealed a sensitivity of 100% and a specificity of 96.1%. Conclusions: Despite using different antigens, both the POC devices showed comparable results to the high complexity ELISA. POC testing for antibodies to SARS-CoV-2 is easier, requires fewer resources than high-complexity lab testing and provides rapid results regarding individual antibody status to SARS-CoV-2. However, the specific test characteristics for each kit must be rigorously evaluated, as they vary substantially.