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Review
. 2021 Jul:108:592-602.
doi: 10.1016/j.ijid.2021.05.029. Epub 2021 May 17.

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

Johannes Hayer  1 , Dusanka Kasapic  2 , Claudia Zemmrich  3
Affiliations
Review

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

Johannes Hayer et al. Int J Infect Dis. 2021 Jul.

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; Immunoassay; Lateral flow; Point-of-care testing; Rapid antigen test; SARS-CoV-2.

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Figures

None
Graphical abstract
Figure 1
Figure 1
Flowchart of search results.a aNo publications were identified from the COVID-19 Diagnostic Devices and Test Method Database (European Commission, 2020). Ct, cycle threshold.
Figure 2
Figure 2
Forest plot of studies evaluating rapid antigen test sensitivity, grouped by test manufacturer/distributor. CI, confidence interval.
Figure 3
Figure 3
SROC plots for all rapid antigen tests.a aStudy result for RapiGEN lies outside the plotting region (x = 0.55, y = 0.525) and is therefore not shown. CI, confidence interval; Coris, Coris BioConcept; SDB, SD biosensor; SROC, summary receiver operating characteristic; Roche, Roche Diagnostics.
Figure 4
Figure 4
Rapid antigen test sensitivity according to viral load (Ct value).a aWhere available, sensitivity estimates derived from a single study are connected by a line. Coris, Coris BioConcept; Ct, cycle threshold; SDB, SD biosensor; Roche, Roche Diagnostics.
See this image and copyright information in PMC

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