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. 2021 Aug 8;10(16):3493.
doi: 10.3390/jcm10163493.

Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients

Shahad Saif Khandker  1 , Nik Haszroel Hysham Nik Hashim  2   3 , Zakuan Zainy Deris  2   3 , Rafidah Hanim Shueb  2 , Md Asiful Islam  4
Affiliations

Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients

Shahad Saif Khandker et al. J Clin Med. .

Abstract

Early diagnosis is still as crucial as the initial stage of the COVID-19 pandemic. As RT-PCR sometimes is not feasible in developing nations or rural areas, health professionals may use a rapid antigen test (RAT) to lessen the load of diagnosis. However, the efficacy of RAT is yet to be investigated thoroughly. Hence, we tried to evaluate the overall performance of RAT in SARS-CoV-2 diagnosis. Based on our PROSPERO registered protocol (CRD42021231432), we searched online databases (i.e., PubMed, Google Scholar, Scopus, and Web of Science) and analysed overall pooled specificity and sensitivity of RAT along with study quality, publication bias, heterogeneity and more. The overall pooled specificity and sensitivity of RAT were detected as 99.4% (95% CI: 99.1-99.8; I2 = 90%) and 68.4% (95% CI: 60.8-75.9; I2 = 98%), respectively. In subgroup analyses, nasopharyngeal specimens and symptomatic patient's samples were more sensitive in RAT, while cycle threshold (Ct) values were found to have an inverse relationship with sensitivity. In the European and American populations, RAT showed better performance. Although the sensitivity of RAT is yet to be improved, it could still be an alternative in places with poor laboratory set up. Nevertheless, the negative samples of RAT can be re-tested using RT-PCR to reduce false negative results.

Keywords: COVID-19; SARS-CoV-2; rapid antigen test; sensitivity; specificity.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
PRISMA flow diagram of study selection.
Figure 2
Figure 2
Funnel plots representing no evidence of significant publication bias estimating (A) specificity and (B) sensitivity of rapid antigen tests in confirming COVID-19.
Figure 3
Figure 3
Forest plots representing estimating of (A) specificity and (B) sensitivity of rapid antigen tests in confirming COVID-19.
Figure 3
Figure 3
Forest plots representing estimating of (A) specificity and (B) sensitivity of rapid antigen tests in confirming COVID-19.
Figure 4
Figure 4
Galbraith plots representing outlier studies estimating (A) specificity and (B) sensitivity of rapid antigen tests in confirming COVID-19.
See this image and copyright information in PMC

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