Standardization of a flow cytometry SARS-CoV-2 serologic test.
Carl Simard1, Jonathan Richard2,3, Renée Bazin1
1Affaires Médicales et Innovation, Héma-Québec, 1070 Avenue des Sciences-de-la-Vie, Québec, QC G1V 5C3 Canada.
Cytotechnology
|January 10, 2022
Summary
A new flow cytometry assay for SARS-CoV-2 (the virus causing COVID-19) was developed and standardized. This assay accurately detects antibodies, showing high specificity and sensitivity for reliable serological testing in laboratories.
Area of Science:
- Immunology
- Virology
- Biotechnology
Background:
- The SARS-CoV-2 virus caused a global pandemic, leading to millions of deaths.
- Understanding the humoral immune response to SARS-CoV-2 is crucial.
- Previous serological assays have limitations, necessitating complementary methods.
Purpose of the Study:
- To refine and standardize a flow cytometry assay for SARS-CoV-2 antibody detection.
- To ensure the assay's reliability for inter-laboratory use.
- To establish performance metrics for this novel serological tool.
Main Methods:
- Optimization of a flow cytometry protocol using SARS-CoV-2 Spike protein-expressed cells.
- Standardization involved suspension cell culture and Mean Equivalent Soluble Fluorochrome (MESF) reporting.
- Reproducibility was assessed across different cytometers, days, and time points up to 72 hours post-staining.
Main Results:
- The optimized assay demonstrated excellent performance with an Area Under the Curve (AUC) of 0.996.
- High specificity (100%) and sensitivity (97.7%) were achieved.
- The assay showed good reproducibility and stability over time.
Conclusions:
- The standardized flow cytometry assay is a reliable method for SARS-CoV-2 serological testing.
- It can serve as a high-throughput confirmatory assay in diagnostic laboratories.
- This method offers a valuable tool for monitoring humoral immunity post-infection or vaccination.
