Diagnostic utility of antigen detection rapid diagnostic tests for Covid-19: a systematic review and meta-analysis

  1. Somaye Ghasemi
  2. Narges Nazari Harmooshi
  3. Fakher Rahim

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Abstract

Background

The early detection of coronavirus disease (COVID-19) infection to improve disease management becomes the greatest challenge. Despite the high sensitivity of RT-PCR, not only it was reported that 20–67% of infected patients had false-negative results. Rapid diagnostic tests (RDTs) are widely used as a point-of-care test for SARS-CoV-2 detection in pharyngeal and blood specimens. It’s more appealing since it’s less time-consuming, doesn’t seem to be as expensive, and doesn’t need any specific training, but the poor sensitivity is the major limitation. Several reports indicated the rapid test of blood and pharyngeal samples has the same sensitivity as the RT-PCR, but some reports have lower sensitivity, especially in asymptomatic patients.

Methods

In the present survey, we investigate the eligible studies for the sensitivity and specificity of rapid tests and explore the factors that influence the result to help better diagnose COVID-19 infection. 20 studies met the inclusion criteria which imposed 33 different tests.

Results

Our findings showed the type of sample, the type of assay, the time of sampling, and the load of virus influence on the sensitivity of RDTs.

Conclusion

This research extends our knowledge of how to improve the sensitivity of RDTs to better diagnose the infected patients to address the controlling COVID-19 pandemic.

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  1. Version published to 10.1186/s13000-022-01215-6
  2. Version published to 10.21203/rs.3.rs-764283/v1 on Research Square
  3. ScreenIT

    SciScore for 10.1101/2021.04.02.21254714: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Search Strategy: To evaluate the usability of rapid tests compare with RT-PCR, we systematically searched the electronic database, including Scopus, Medline/PubMed, EMBASE, Web of sciences (WOS), and Cochrane library using Mesh-standardized keywords: (((Rapid antigen detection test * OR RDT*) OR “Rapid Antigen Test ”[Mesh] OR “point of care testing”) AND (“Real-time PCR”
    EMBASE
    suggested: (EMBASE, RRID:SCR_001650)
    Cochrane library
    suggested: (Cochrane Library, RRID:SCR_013000)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  4. Version published to 10.1101/2021.04.02.21254714 on medRxiv