SARS-CoV-2 antibody tests are available in various formats, detecting different viral target proteins and antibody subclasses. The specificity and sensitivity of SARS-CoV-2 antibody tests are known to vary and very few studies have addressed the performance of these tests in COVID-19 patient groups at different time points. We here compared the sensitivity and specificity of seven commercial (SNIBE, Epitope, Euroimmun, Roche, Abbott, DiaSorin, Biosensor) and two in-house LIPS assays (LIPS N and LIPS S-RBD) IgG/total Ab tests in serum samples from 97 COVID-19 patients and 100 controls, and correlated the results with the patients’ clinical data and the time-point the test was performed. We found a remarkable variation in the sensitivity of antibody tests with the following performance: LIPS N (91.8%), Epitope (85.6%), Abbott and in-house LIPS S-RBD (both 84.5%), Roche (83.5%), Euroimmun (82.5%), DiaSorin (81.4%), SNIBE (70.1%), and Biosensor (64.9%). The overall agreement between the tests was between 71–95%, whereas the specificity of all tests was within 98–100%. The correlation with patients’ clinical symptoms score ranged from strongest in LIPS N (ρ = 0.41; p<0.001) to nonsignificant in LIPS S-RBD. Furthermore, the time of testing since symptom onset had an impact on the sensitivity of some tests. Our study highlights the importance to consider clinical symptoms, time of testing, and using more than one viral antigen in SARS-CoV-2 antibody testing. Our results suggest that some antibody tests are more sensitive for the detection of antibodies in early stage and asymptomatic patients, which may explain the contradictory results of previous studies and should be taken into consideration in clinical practice and epidemiological studies.
Background. High number of SARS-CoV-2 antibody tests are available in different formats, detect different types of antibodies, and use different target proteins. Sensitivity of these tests varies and could be also related to clinical symptoms and testing time. Methods. Serum samples from 97 COVID-19 patients and 100 controls were tested with 9 antibody tests (SNIBE, Epitope, Euroimmun, Roche, Abbott, DiaSorin, Biosensor, LIPS N, and LIPS S-RBD). The results were analyzed in context of clinical data. Findings. Positivity rate was of tests was following: N-LIPS test (91.8% cases), Epitope (85.6%), Abbott and in-house LIPS S-RBD (both 84.5%), Roche (83.5%), Euroimmun (82.5%), DiaSorin (81.4%), SNIBE (70.1%), and Biosensor (64.9%). Agreement between tests varied (71-95%). Correlation between patient symptoms score and antibody value was test-dependent: varied from strongest in LIPS N (rho=0.41; p<0.001) to nonsignificant (LIPS S-RBD). Testing time from symptoms influenced sensitivity in some tests more than anothers. Interpretation. Sensitivity of tests varied highly and combination of different tests may improve it. Relation of results to symptoms and testing time was test-dependent. Thus, some antibody tests seems to be more sensitive to detect antibodies early and in asymptomatic patients than others. Funding. Study was funded by SYNLAB Estonia and Estonian Research Council grant PRG377.
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