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Rapid antibody diagnostics for SARS-CoV-2 adaptive immune response
Adeel Afzal1, Naseer Iqbal1, Saima Feroz2
1Department of Chemistry, College of Science, University of Hafr Al Batin, PO Box 1803, Hafr Al Batin, 39524, Saudi Arabia.
Analytical Methods : Advancing Methods and Applications
|September 23, 2021
Summary
Rapid antibody tests for COVID-19 (coronavirus disease 2019) showed variable performance. This review compares claimed versus independent evaluations of diagnostic accuracy, highlighting issues for future development.
Area of Science:
- Biomedical diagnostics
- Infectious disease epidemiology
- Immunological assays
Background:
- The COVID-19 pandemic spurred rapid development of diagnostic tests.
- Emergency use authorizations led to concerns about test accuracy and reliability.
- Variable performance of rapid antibody tests can cause diagnostic ambiguity.
Purpose of the Study:
- To compare claimed clinical sensitivity and specificity of commercial COVID-19 antibody tests with independent performance evaluations.
- To summarize working principles and clinical efficiencies of modern antibody diagnostics.
- To identify research, development, and commercialization challenges for antibody tests.
Main Methods:
- Systematic review of commercially available rapid antibody diagnostics for COVID-19.
- Comparison of manufacturer-reported performance data with results from independent clinical evaluations.
- Analysis of diagnostic accuracy metrics, including clinical sensitivity and specificity.
Main Results:
- Significant variability observed in the clinical performance of rapid antibody tests.
- Discrepancies noted between claimed and independently evaluated sensitivity and specificity.
- Antibody tests are better suited for epidemiological surveillance and immune response assessment than early diagnosis.
Conclusions:
- Independent evaluation is crucial for assessing the true performance of diagnostic tests.
- Addressing variability in antibody test accuracy is essential for reliable public health decision-making.
- Future research should focus on improving the standardization and validation of diagnostic assays for infectious diseases.
