Target specific serologic analysis of COVID-19 convalescent plasma.

Area of Science:

• Immunology
• Infectious Diseases
• Medical Diagnostics

Background:

• Accurate serological testing is crucial for understanding SARS-CoV-2 infection dynamics.
• Evaluating the performance of available diagnostic assays is essential for clinical application.

Purpose of the Study:

• To compare the clinical performance of four distinct Coronavirus Disease 2019 (COVID-19) serology assays.
• To investigate the correlation between COVID-19 disease history and serology assay performance.

Main Methods:

• Comparative analysis of four serology assays: Genalyte Maverick, Roche Elecsys, Beckman Coulter Access, and DiaSorin LIAISON.
• Testing of clinical samples (pre-December 2019) and convalescent plasma donor samples (COVID-19 positive by PCR).
• Assessment of assay specificity and clinical sensitivity, with correlation analysis against self-reported disease history.

Main Results:

• All four assays exhibited high specificity (100%).
• Clinical sensitivity varied: Genalyte (98%), Roche (96%), DiaSorin (92%), and Beckman Coulter (87%).
• Statistically significant differences in sensitivity were found between Beckman Coulter and both Genalyte and Roche assays. No correlation between disease history and false negatives was observed.

Conclusions:

• The Genalyte Multiplex assay demonstrated comparable or superior sensitivity to other validated assays.
• Assay specificity was uniformly high across all tested platforms.
• COVID-19 disease history did not correlate with serological assay performance in this study.