Neutralizing antibody responses following natural SARS-CoV-2 infection: Dynamics and correlation with commercial serologic tests.

The prediction of SARS-CoV-2 immunity by commercially available serologic tests will be crucial to assess the efficacy of vaccination. We used plaque reduction neutralization testing as the reference standard to evaluate the diagnostic performance of six commercial serologic tests for monitoring SARS-CoV-2 neutralizing antibodies. Euroimmun ELISA anti-spike 1 IgG, Euroimmun anti-spike 1 IgG QuantiVac ELISA, Elecsys Anti-nucleocapsid protein total antibodies, Elecsys Anti-receptor-binding domain total antibodies, VIDAS anti-spike subdomain IgG, and Microblot-Array COVID-19 IgG assay were performed on 228 sera from 89 healthcare workers who participated in a six-month seroprevalence survey. Although all immunoassays demonstrated similar performances, VIDAS SARS-CoV-2 IgG and Euroimmun QuantiVac IgG (area under the curve 0.96 and 0.95 respectively) showed the better ability to detect Nabs. Except for the Elecsys Anti-SARS-CoV-2 and the Elecsys Anti-SARS-CoV-2 S assays, the commercial serologic tests evaluated here showed a significant decrease of antibody titers in the 6-month follow-up samples. Depending on the immunoassay, 21% to 33% of the participants became seronegative, and 16.9% had a loss of neutralizing antibodies. Microblot-Array assay results showed cross-reactivity with HCoVNL63 in only one sample, and this sample showed SARS-CoV-2 neutralizing capacity. In conclusion, our results support the use of VIDAS SARS-CoV-2 IgG, Euroimmun Anti-SARS-CoV-2 ELISA IgG, Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA IgG and Microblot-Array COVID-19 IgG assays to monitor neutralizing antibody response following natural SARS-CoV-2 infection. These immunoassays could facilitate the prediction of post-vaccine protection in the long term and the allocation of booster doses.

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform.

Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions. Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients. Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs. Conclusion: Using tests not considered the "gold standard" for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients.

Monitoring antibody response following SARS-CoV-2 infection: diagnostic efficiency of 4 automated immunoassays.

INTRODUCTION: SARS-CoV-2 seroconversion is important for epidemiological studies as well as contact tracing. MATERIAL AND METHODS: The antibody response against SARS-CoV-2 was examined in 111 patients with a positive qRT-PCR. Seroconversion was assessed using the Elecsys from Roche, the Liaison S1/S2 IgG from Diasorin, the IgG and IgA from Euroimmun, as well as the VIDAS IgG and IgM. Specificity was estimated based on the measurement of SARS-CoV-2 antibodies in 96 residual samples collected during a non-pandemic period. RESULTS: The highest overall sensitivity for detecting seroconversion was obtained using the Elecsys (81.1%), the Euroimmun with a combined detection of IgG/IgA (86.5%), and the VIDAS with a simultaneous measurement of IgG/IgM (78.4%).The Elecsys and the VIDAS IgG/IgM demonstrated a specificity as well as a positive predictive value of 100%. CONCLUSIONS: The Elecsys and the VIDAS methods with a combination of IgG/IgM measurement demonstrated a high sensitivity with no false positive results.