Limits and Opportunities of SARS-CoV-2 Antigen Rapid Tests: An Experienced-Based Perspective

  1. Verena Schildgen
  2. Sabrina Demuth
  3. Jessica Lüsebrink
  4. Oliver Schildgen

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Abstract

Background: Due to the steadily rising case numbers of SARS-CoV-2 infections worldwide, there is an increasing need for reliable rapid diagnostic devices in addition to existing gold standard PCR methods. Actually, public attention is focused on antigen assays including lateral flow tests (LFTs) as a diagnostic alternative. Therefore, different LFTs were analyzed regarding their performance in a clinical setting. Material and Methods: A pilot sample panel of 13 bronchoalveolar fluids (BALFs) and 60 throat washing (TW) samples with confirmed PCR results, as well as eight throat washes invalid by PCR, were tested with the BIOCREDIT test (RapiGEN), the PanbioTM assay (Abbott), and the SARS-CoV-2 rapid antigen test (Roche). Conclusion: The analyzed antigen test showed an interassay correlation of 27.4%, with overall specificities ranging from 19.4% to 87.1%, while sensitivities of the respective tests ranged between 33.3% and 88.1%. Because these assays did not entirely meet all high expectations, their benefit has to be carefully evaluated for the respective test strategy and setting.

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  1. ScreenIT

    SciScore for 10.1101/2020.09.22.20199372: (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
    We compared the BIOCREDIT assay of RapiGEN, the Panbio™ assay of Abbott, and the SARS-CoV-2 Rapid Antigen Test of Roche.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    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: We detected the following sentences addressing limitations in the study:
    This conclusion is supported by the manufacturer’s recommendations, who explicitly claim that their assays are not approved as stand-alone diagnostic and the limitations that the assay should be performed “in patients with clinical symptoms” (RapiGEN) or that the test “is not intended to detect from defective (non-infectious) virus during the later stages of viral shedding that might be detected by PCR molecular tests” (Abbott). This means that these assays are not appropriate for the screening of asymptomatic individuals and cannot be recommended to date to be broadly used in any setting in which reliable diagnostics are crucial to avoid spreading of the virus, such as hospitals and long-term care facilities for the elderly or other risk groups, especially, as limited information on host and viral factors influencing shedding of SARS-CoV-2 antigens and their correlation to infectious viruses impede any prognosis on infectivity. Although it actually seems that exclusive antigen tests have research character rather than being true IVDs and unfortunately cannot replace PCR assays, they should additionally be used to gain deeper insights into infectivity and the course of infection to develop more advanced testing strategies.

    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.

  2. Version published to 10.3390/pathogens10010038
  3. Version published to 10.1101/2020.09.22.20199372 on medRxiv