Evaluation of the test accuracy of a SARS-CoV-2 rapid antigen test in symptomatic community dwelling individuals in the Netherlands

  1. Nathalie Van der Moeren
  2. Vivian F. Zwart
  3. Esther B. Lodder
  4. Wouter Van den Bijllaardt
  5. Harald R. J. M. Van Esch
  6. Joep J. J. M. Stohr
  7. Joost Pot
  8. Ineke Welschen
  9. Petra M. F. Van Mechelen
  10. Suzan D. Pas
  11. Jan A. J. W. Kluytmans

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Abstract

SARS-CoV-2 real-time reverse transcriptase polymerase chain reaction (qRT-PCR) is well suited for the diagnosis of clinically ill patients requiring treatment. Application for community testing of symptomatic individuals for disease control purposes however raises challenges. SARS-CoV-2 rapid antigen tests might offer an alternative, but quality evidence on their performance is limited.

Methods

We conducted an evaluation of the test accuracy of the ‘BD Veritor System for Rapid Detection of SARS-CoV-2’ (VRD) compared to qRT-PCR on combined nose/throat swabs obtained from symptomatic individuals at Municipal Health Service (MHS) COVID-19 test centers in the Netherlands. In part one of the study, with the primary objective to evaluate test sensitivity and specificity, all adults presenting at one MHS test center were eligible for inclusion. In part two, with the objective to evaluate test sensitivity stratified by Ct (cycle threshold)-value and time since symptom onset, adults who had a positive qRT-PCR obtained at a MHS test center were eligible.

Findings

In part one (n = 352) SARS-CoV-2 prevalence was 4.8%, overall specificity 100% (95%CI: 98·9%-100%) and sensitivity 94·1% (95%CI: 71·1%-100%). In part two (n = 123) the sensitivity was 78·9% (95%CI: 70·6%-85·7%) overall, 89·4% (95% CI: 79·4%-95·6%) for specimen obtained within seven days after symptom onset and 93% (95% CI: 86%-97.1%) for specimen with a Ct-value below 30.

Interpretation

The VRD is a promising diagnostic for COVID-19 testing of symptomatic community-dwelling individuals within seven days after symptom onset in context of disease control. Further research on practical applicability and the optimal position within the testing landscape is needed.

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  1. Version published to 10.1371/journal.pone.0250886
  2. ScreenIT

    SciScore for 10.1101/2020.10.19.20215202: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Individuals who were able and willing to give verbal informed consent were included.
    IRB: The study protocol was submitted at the medical ethical board ‘Medical research Ethics Committees United’ (MEC-U) and was granted an exemption of the Dutch medical scientific research act (WMO).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    (3) Real-time reverse transcriptase PCR: Two CE-IVD labelled qPCR platforms were used: the Cobas 6800 (Roche) and the m2000 (Abbott).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    All data were analysed using Excel and SPSS version 24.
    Excel
    suggested: None
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    The lack of data on this early window is a limitation of the study. COVID-19 infectivity peaks during the period shortly before and after the onset of symptoms when also maximal viral loads in upper respiratory tract material are measured. (7,8) In this context the test performance for specimen with a qRT-PCR Ct-value beneath 30 was calculated. As this cut off was based on the obtained data, it is to be confirmed by prospective evaluations. In order to optimise standardisation, specimens were transported to the laboratory where the VRD was performed by trained technicians. As the final objective is to perform the VRD at the COVID-19 test centres, further research on test accuracy in point of care setting is needed. In order to perform the VRD at the laboratory, samples needed to be stored and transported on dry ice in accordance with the manufacturers’ prescriptions. Partial destruction of antigen due to freezing cannot be excluded and could have resulted in an underestimation of the clinical test sensitivity. The presence of COVID-19 like symptoms is a pre-requisite to be tested at a GGD test-centre. As clients make their own appointment trough a digital system, we cannot exclude a small number of asymptomatic individuals amongst the included individuals in part one of the study. In part two of the study three asymptomatic subjects were excluded. The current gold standard for diagnosis of an active SARS-CoV-2 infection is qRT-PCR. This highly sensitive and specific test is o...

    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.

  3. Version published to 10.1101/2020.10.19.20215202 on medRxiv