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Serological Assays for Assessing Postvaccination SARS-CoV-2 Antibody Response
Sally A Mahmoud1, Subhashini Ganesan2, Shivaraj Naik1
1Biogenix Lab G42, Masdar City, Abu Dhabi, United Arab Emirates.
Microbiology Spectrum
|September 29, 2021
Summary
This study evaluated six commercial SARS-CoV-2 antibody tests against the gold standard. Diasorin-TrimericS IgG showed the best overall performance, and adjusting Genscript cPass cutoffs improved its accuracy for COVID-19 antibody detection.
Area of Science:
- Virology and Immunology
- Diagnostic Assay Development
- Public Health Surveillance
Background:
- Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies are vital for COVID-19 pandemic control and surveillance.
- Numerous commercial assays exist, but performance evaluations are limited, necessitating comparative studies.
- Understanding assay performance is crucial for interpreting post-vaccination antibody status and immune response.
Purpose of the Study:
- To evaluate and compare the performance of six commercially available SARS-CoV-2 antibody serological assays.
- To identify assays with optimal sensitivity, specificity, and agreement with the gold standard plaque reduction neutralization test (PRNT).
- To assess the impact of adjusting assay cutoff values on performance metrics.
Main Methods:
- Performance evaluation of six commercial SARS-CoV-2 antibody assays: Genscript cPass, Diasorin-S1/S2 IgG, Alinity IgG II, Diasorin-TrimericS IgG, Roche Elecsys, and AESKULISA.
- Comparison of assay results against the gold standard plaque reduction neutralization test (PRNT).
- Analysis of receiver operating characteristic (ROC) curves to optimize cutoff values, specifically for Genscript cPass.
Main Results:
- Roche Elecsys demonstrated the highest sensitivity, while Genscript cPass exhibited the highest specificity.
- Diasorin-TrimericS IgG showed the best overall performance and highest agreement with PRNT results.
- Optimizing Genscript cPass by lowering the cutoff from 30% to 20% significantly improved sensitivity and overall agreement with PRNT.
Conclusions:
- Commercially available serological assays offer viable alternatives to the standard PRNT for SARS-CoV-2 antibody detection.
- Diasorin-TrimericS IgG and Genscript cPass (with adjusted cutoff) are recommended for evaluating post-vaccination antibody status.
- Further research with larger sample sizes is needed to optimize cutoff values and assess cost-effectiveness for widespread use.
