Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as of November 20, 2020

Abstract

Objectives: Rapid antigen tests, or RATs, are a type of lateral flow chromatographic immunoassay utilized to aid the diagnosis of SARS-CoV-2 infection. We performed a systematic meta-analysis to compare the real-world performance of commercially available RATs. Methods: We searched several databases and websites for manufacturer-independent prospective clinical performance studies comparing SARS-CoV-2 RATs and RT-PCR. Only studies on RATs that did not need a separate reader for result retrieval and that reported data on viral load, patients’ symptom status, sample type, and PCR assay used were included. Results: 19 studies utilizing 11,109 samples with 2,509 RT-PCR-positives were included. RAT sensitivity varied between 28.9% (95% CI 16.4–44.3) and 98.3% (95% CI 91.1–99.7), likely dependent upon population characteristics, viral load, and symptom status. RAT specificity varied between 92.4% (95% CI 87.4–95.9) and 100% (95% CI 99.7–100) with one outlier. The RATs by Roche Diagnostics/SD Biosensor and Abbott had the highest pooled sensitivity (82.4% [95% CI 74.2–88.4] and 76.9% [95% CI 72.1–81.2], respectively). Sensitivity in high-viral-load samples (cycle threshold ≤25) showed heterogeneity among the different RATs. Conclusion: The RATs offered by Roche Diagnostics/SD Biosensor and Abbott provide sufficient manufacturer-independent, real-world performance data to support their use to detect current SARS-CoV-2 infection, particularly in high-viral-load populations.

Keywords

• COVID-19
• SARS-CoV-2
• Rapid antigen test
• Point-of-care testing
• Immunoassay
• Lateral flow