Serological determinants of COVID-19

Area of Science:

• Immunology
• Infectious Diseases
• Diagnostic Technologies

Background:

• The rapid global spread of SARS-CoV-2 necessitated reliable diagnostic tools.
• Serological tests for IgM and IgG antibodies became crucial for tracking and containing the pandemic.
• Evaluating the performance of different immunoassay methods is essential for accurate COVID-19 diagnosis.

Purpose of the Study:

• To compare the sensitivity and specificity of point-of-care test (POCT) lateral flow immunoassay (FIA) against automated chemiluminescent immunoassay (CLIA) for detecting SARS-CoV-2 IgM and IgG antibodies.
• To assess the diagnostic accuracy of FIA for COVID-19 antibody detection.

Main Methods:

• Comparative study design.
• Utilized point-of-care test (POCT) lateral flow immunoassay (FIA).
• Compared FIA results against automated chemiluminescent immunoassay (CLIA) as the gold standard.

Main Results:

• Significant differences in sensitivity and specificity were observed between IgM and IgG antibody tests.
• The IgM POCT FIA method demonstrated low sensitivity (0.526) compared to CLIA.
• The IgG POCT FIA method exhibited high sensitivity (0.937) compared to CLIA, suggesting comparable diagnostic information.

Conclusions:

• The IgG FIA method shows high sensitivity for detecting SARS-CoV-2 antibodies.
• FIA may be a valuable tool for rapid assessment of potential contagiousness, particularly for individuals unable to maintain social distancing.
• Further validation of FIA performance for IgM detection is warranted.