Performance analysis among multiple fully automated anti-SARS-CoV-2 antibody measurement reagents: A potential indicator for the correlation of protection in the antibody titer.

BACKGROUND

To evaluate the performance of various reagents in automated analyzers for antibody detection against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

METHODS

Using 100 serum samples from 100 individual patients diagnosed with SARS-CoV-2 infection, the precision, linearity, determination agreement, and correlation of five qualitative reagents (Elecsys Anti-SARS-CoV-2, ARCHITECT SARS-CoV-2 IgG, ARCHITECT SARS-CoV-2 IgM, Access SARS-CoV-2 IgM, and SARS-CoV-2 IgM) and four quantitative reagents (Elecsys Anti-SARS-CoV-2 S, ARCHITECT SARS-CoV-2 IgG II, Access SARS-CoV-2 IgG 1st IS, and SARS-COV-2 IgG S) were analyzed. A surrogate virus-neutralizing test (sVNT) kit was used to evaluate the measurement value of each quantitative reagent corresponding to the amount of neutralizing antibody, similar to that of patients in the late stage of infection.

RESULTS

Precision and linearity were found to be sufficient for clinical use. Five discrepant samples were observed in the positive and negative judgments of the qualitative reagents for IgG, and one discrepant sample was observed in the qualitative reagent for IgM. Although the measurement values of the quantitative reagents were different, they were correlated with each reagent. The reference values inferred from the sVNT were Elecsys Anti-SARS-CoV-2: 71.8 U/L, ARCHITECT SARS-CoV-2 IgGⅡ: 2976.3 AU/mL, Access SARS-CoV-2 IgG 1st IS: 689.6 IU/mL, and SARS-CoV-2 IgG S: 19.3 U/L.

CONCLUSIONS

The performance observed for each anti-SARS-CoV-2 antibody detection reagent was sufficient. The reference values based on the inhibition rate of sVNT have potential as indicators of the correlation of protection and are expected to be leveraged in automated antibody tests.