Evaluation of the Panbio ™ rapid antigen test for COVID-19 diagnosis in symptomatic health care workers

  1. Marjan J. Bruins
  2. Claudy Oliveira dos Santos
  3. Marjan Spoelman-Lunsche
  4. Marieke I. van den Bos-Kromhout
  5. Sylvia B. Debast

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Abstract

If a health care workers (HCW) experiences COVID-19 associated symptoms, SARS-CoV-2 testing must be performed as soon as possible, to prevent transmission of the virus and to guarantee continuity of care. The gold standard for the detection of SARS-CoV-2, RT-PCR, has a high sensitivity but usually takes 6-8 hours. Lateral flow antigen assays take only 15-30 minutes and do not need any high tech equipment.

In a prospective study of our hospital’s HCWs, we evaluated the sensitivity of the Panbio™ COVID-19 Ag Rapid Test (Abbott) against the molecular test Aptima™ SARS-CoV-2 Assay (Hologic) which uses Transcription Mediated Amplification (TMA). TMA positive samples were further subjected to a quantitative real-time SARS-CoV-2 PCR to obtain Ct values as an indication of the viral load.

Of 1101 HCWs included in the study between November 2020 and February 2021, 84 (7.6%) were TMA positive, of which 48 (57.1%) were antigen test positive. Most false negative antigen test results occurred if the duration of symptoms had been ≤1 day or ≥7 days. Sensitivities for symptom onset of ≤1, 2 or 3 days were 47.1%, 63.0% and 66.7% respectively.

The Panbio™ rapid test is fast and easy to perform, but is not a suitable SARS-CoV-2 test to confirm or exclude COVID-19 in HCWs with a very recent onset of symptoms.

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  1. ScreenIT

    SciScore for 10.1101/2021.06.21.21259234: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Ethics approval and informed consent: The local Medical Research Ethics Committee considered the study not subject to the Dutch Medical Research Involving Human Subjects Act (WMO) and declared it to be exempted from further review.
    IRB: Ethics approval and informed consent: The local Medical Research Ethics Committee considered the study not subject to the Dutch Medical Research Involving Human Subjects Act (WMO) and declared it to be exempted from further review.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Panbio™ COVID-19 Ag Rapid Test: The Panbio™ COVID-19 Ag Rapid Test (Abbott, Lake Country, IL, USA) is a lateral flow assay which detects SARS-CoV-2 nucleocapsid protein in nasopharyngeal specimens.
    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:
    A limitation of our study was that we were not able to actively follow-up on symptomatic HCWs who tested Aptima positive and antigen test negative, to see whether the antigen test would become positive in the following days. Still, 81 HCWs were tested with both NAAT and antigen test more than once, of whom 21 made a new appointment because symptoms persisted or worsened For these however, test results of first and repeat sampling were all negative, except for one HCW who tested Aptima positive and antigen test negative in the first round (and negative for both in the second tests), probably due to a much earlier acquired, previous infection (symptoms onset 28 days ago, Ct value 32.6). In other studies evaluating the Panbio™ COVID-19 Ag Rapid test, sensitivity ranging from 72% to 91% was found among symptomatic patients7,10,11,12,13,14,15. Specificity was almost always 100%. Sensitivities increased to over 90% at a Ct value of lower than 24, representing a peak viral load in the first week of infection and presumably indicating a limit of infectiousness16. This confirms the usefulness of the rapid antigen test for diagnosing COVID-19 in a high prevalence population with symptom onset of several days, according to the WHO’s recommendations6. In previous studies however, the relation between duration of symptoms and antigen test results was not assessed for subjects with symptoms onset of ≤ 24 hours10,15,17. To our knowledge, ours is the first study evaluating this among HCWs. T...

    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.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  2. Version published to 10.1101/2021.06.21.21259234v1 on medRxiv