Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis - PubMed (original) (raw)

Review

Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis

Anastasia Tapari et al. Diagnostics (Basel). 2022.

Abstract

Coronavirus disease 2019 (COVID-19) initiated global health care challenges such as the necessity for new diagnostic tests. Diagnosis by real-time PCR remains the gold-standard method, yet economical and technical issues prohibit its use in points of care (POC) or for repetitive tests in populations. A lot of effort has been exerted in developing, using, and validating antigen-based tests (ATs). Since individual studies focus on few methodological aspects of ATs, a comparison of different tests is needed. Herein, we perform a systematic review and meta-analysis of data from articles in PubMed, medRxiv and bioRxiv. The bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities was used. Most of the AT types for SARS-CoV-2 were lateral flow immunoassays (LFIA), fluorescence immunoassays (FIA), and chemiluminescence enzyme immunoassays (CLEIA). We identified 235 articles containing data from 220,049 individuals. All ATs using nasopharyngeal samples show better performance than those with throat saliva (72% compared to 40%). Moreover, the rapid methods LFIA and FIA show about 10% lower sensitivity compared to the laboratory-based CLEIA method (72% compared to 82%). In addition, rapid ATs show higher sensitivity in symptomatic patients compared to asymptomatic patients, suggesting that viral load is a crucial parameter for ATs performed in POCs. Finally, all methods perform with very high specificity, reaching around 99%. LFIA tests, though with moderate sensitivity, appear as the most attractive method for use in POCs and for performing seroprevalence studies.

Keywords: COVID-19; SARS-CoV-2; antigen test; diagnostic performance; meta-analysis; sensitivity; specificity.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram.

Figure 2

Figure 2

Performance of POC (LFIA and FIA) and laboratory (CLEIA) antigen-based methods in terms of sensitivity. All included assays in the meta-analysis use samples with Ct < 40 and test cumulatively both the nucleocapsid and Spike antigen. Numbers above the bars depict sensitivity values/number of studies included in each meta-analysis.

Figure 3

Figure 3

Performance of LFIA and FIA methods (N antigen-based) in terms of sensitivity on NSP samples in symptomatic vs. asymptomatic persons. Included assays in the meta-analysis are performed with positive samples for either Ct < 30 or Ct < 40. Numbers above the bars depict sensitivity values/number of studies included in each meta-analysis.

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