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Assay Harmonization Study To Measure Immune Response to SARS-CoV-2 Infection and Vaccines: a Serology Methods Study.
Troy J Kemp1, Heidi A Hempel1, Yuanji Pan1
1Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Microbiology Spectrum
|May 16, 2023
Summary
This study evaluated SARS-CoV-2 serology assays, finding that commercial assays offer high specificity and in-house assays provide excellent sensitivity. Harmonization using the WHO International Standard improved performance, suggesting binding immunoassays are practical alternatives for large-scale COVID-19 serological studies.
Area of Science:
- Immunology and Infectious Diseases
- Diagnostic Assay Development
- Public Health
Background:
- The COVID-19 pandemic necessitated rapid development of SARS-CoV-2 serology assays.
- Significant variability in assay performance and lack of standardization hindered data comparison.
- Need for reliable assays to assess immune response to SARS-CoV-2 infection and vaccination.
Purpose of the Study:
- To analyze the reliability, sensitivity, specificity, and reproducibility of commercial, in-house, and neutralization SARS-CoV-2 serology assays.
- To evaluate the feasibility of using the WHO International Standard (IS) for assay harmonization.
- To assess binding immunoassays as practical alternatives to neutralization assays for large-scale studies.
Main Methods:
- Evaluation of multiple commercial, in-house, and neutralization serology assays using a standardized sample set.
- Assessment of assay performance metrics including sensitivity, specificity, and reproducibility.
- Application of WHO IS for standardization and harmonization across different assay types.
Main Results:
- Commercial assays exhibited the highest specificity; in-house assays demonstrated superior antibody sensitivity.
- Neutralization assays showed variability but correlated well with binding immunoassays.
- WHO IS standardization improved the performance of all evaluated assay types.
Conclusions:
- High-performing SARS-CoV-2 serology assays are available for rigorous evaluation of immune responses.
- Binding immunoassays can serve as practical and accurate proxies for neutralization assays in large sample sets.
- WHO IS standardization is feasible and beneficial for harmonizing diverse serological assays for COVID-19 research.
