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Review
. 2021 May 9;18(4):949-957.
doi: 10.5114/aoms/135910. eCollection 2022.

Diagnostic accuracy of antibody-based rapid diagnostic tests in detecting coronavirus disease 2019: systematic review

Tiara Josephine Gracienta  1 , Ryan Herardi  1 , Frans Santosa  1 , Taufiq Fredrik Pasiak  1 , Yanto Sandy Tjang  1
Affiliations
Review

Diagnostic accuracy of antibody-based rapid diagnostic tests in detecting coronavirus disease 2019: systematic review

Tiara Josephine Gracienta et al. Arch Med Sci. .

Abstract

Introduction: The rapid transmission of coronavirus disease 2019 (COVID-19) requires a fast, accurate, and affordable detection method. Despite doubts of their diagnostic accuracy, rapid diagnostic tests (RDTs) are used worldwide due to their practicality. This systematic review aims to determine the diagnostic accuracy of antibody-based RDTs in detecting COVID-19.

Material and methods: A literature search was carried out on five journal databases using the PRISMA-P 2015 method. We included all studies published up to February 2021. The risk of bias was evaluated using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Diagnostic Test Accuracy Studies. Data regarding peer-review status, study design, test kit information, immunoglobulin class, target antigen, and the number of samples were extracted and tabulated. We estimated the pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with a 95% confidence interval.

Results: Thirty-three studies met the eligibility criteria. The pooled data results showed that the combined detection method of IgM or IgG had the highest sensitivity and NPV, which were 73.41% (95% CI: 72.22-74.57) and 75.34% (95% CI: 74.51-76.16), respectively. The single IgG detection method had the highest specificity and PPV of 96.68% (95% CI: 96.25-97.07) and 95.97% (95% CI: 95.47-96.42%), respectively.

Conclusions: Antibody-based RDTs are not satisfactory as primary diagnostic tests but have utility as a screening tool.

Keywords: COVID-19; diagnostic accuracy; rapid diagnostic test.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
PRISMA flow of literature search process
See this image and copyright information in PMC

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