False-positivity results in rapid antigen tests for SARS-CoV-2: an umbrella review of meta-analyses and systematic reviews

ABSTRACT

Introduction

The rapid antigen detection tests (RADTs) for SARS-CoV-2 infection could contribute to the clinical and public health strategies for managing COVID-19. This umbrella review aimed to explore the accuracy and sensitivity of RADTs for SARS-CoV-2 by assessing the incidence of false positivity associated with them.

Areas covered

Meta-analyses and systematic reviews on the sensitivity and specificity of commercially available RADTs with data on false-positive results were identified by searching the PubMed, EMBASE, Cochrane Library, and Web of Science databases from inception to 31 March 2022. All meta-analyses and systematic reviews on the sensitivity and specificity of rapid antigen tests were included. Data on the author and year, included studies, index tests, sample size, false negatives, false positives, and study quality based on AMSTAR 2 (Assessing the Methodological Quality of Systematic Reviews) rating were extracted from the included meta-analyses and systematic reviews.

Expert opinion

The false positivity rates in the included studies ranged from 0.0% – 4.0%. This study summarizes the available evidence on the incidence of false positivity in RADTs and shows it is less than 4.0%. Therefore, our findings imply that RADTs can be an appropriate, economic, and rapid detection method for mass screening of COVID-19.

KEYWORDS:

• False positivity
• rapid antigen test
• SARS-CoV-2
• sensitivity
• specificity

Declaration of Interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have received an honorarium for their review work. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.