Evaluation of the SARS-CoV-2-IgG response in outpatients by five commercial immunoassays.

Commercially available immunoassays have been developed for sensitive and specific detection of antibodies against SARS-CoV-2. While high sensitivity has been reported in hospitalized COVID-19 patients, little is known about the performance of the assays in ambulatory patients. Therefore, we evaluated the SARS-CoV-2-IgG response in 51 SASR-CoV-2-PCR-confirmed outpatients with five commercial immunoassays. The sensitivity in serum samples, collected at a median of 24 days after onset of symptoms, detected by the Anti-SARS-CoV-2-ELISA IgG (Euroimmun), EDI™ Novel Coronavirus COVID-19 IgG ELISA (Epitope Diagnostics), Liaison^® SARS-CoV-2 S1/S2 IgG (Diasorin), SARS-CoV-2 IgG on the Architect™ i2000 (Abbott), and Elecsys^® Anti-SARS-CoV-2 (IgM/IgA/IgG) on the cobas™ e801 (Roche) was 84.3%, 78.4%, 74.5%, 86.3%, and 88.2%, respectively. The sensitivity in serum samples, collected >20 days after onset of symptoms, varied between 75.0% and 90.0%, and in samples, collected at least 28 days after onset of symptoms, did not increase, except in the Anti-SARS-CoV-2-ELISA IgG by Euroimmun (90.0%). There was not an obvious association between the type of the antigen (N versus S protein) and the overall sensitivity of the assays. Our results show significant individual differences of the IgG response against SARS-CoV-2, additionally confirmed in three patients with follow-up serum samples and seven asymptomatic but PCR-positive contact persons. In conclusion, our study shows that commercially available immunoassays detect SARS-CoV-2-IgG or total antibodies in outpatients with a satisfying sensitivity, but lower than that reported for hospitalized patients. In asymptomatic persons the SARS-CoV-2-IgG response may even be absent in a relevant percentage of persons.