EVALUATION OF THE PANBIO SARS-COV-2 RAPID ANTIGEN DETECTION TEST IN THE BAHAMAS

  1. Christoph Johnson
  2. Kirvina Ferguson
  3. Tavion Smith
  4. Dashaunette Wallace
  5. Keith McConnell
  6. Donaldson Conserve
  7. Indira Martin

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Abstract

Identification and isolation of persons infected with SARS-COV-2 are key mitigation strategies in the current pandemic, and rapid antigen detection tests (RADTs) offer the promise of decreased turnaround time to diagnosis when compared with gold standard RT-PCR testing. We evaluated the analytical performance of the Abbott® Panbio™ RADT on nasopharyngeal samples stored at the Ministry of Health National Reference Lab in Nassau, Bahamas. The Panbio™ demonstrated a test sensitivity of 94% and a specificity of 100% on 50 PCR negative samples and 50 samples presumed to be infectious based on having PCR cycle threshold values below 30. Additionally, in our examination of operator results there was low interpersonal variation (1%) among three blind operators and significant correlation between sample Ct value and perceived signal strength on the RADT device. However, three PCR positive samples below Ct 30 were misdiagnosed by RADT, including one sample with Ct value less than 20. These results support the use of the Panbio™ in symptomatic persons to detect active SARS-COV-2 infections, with the caveat that RADT-negative samples should be confirmed by RT-PCR.

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  1. ScreenIT

    SciScore for 10.1101/2021.07.13.21260402: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingRADT performance and results interpretation was performed by three independent operators concurrently performing blind testing; operators were asked to score their results as negative (score of 0), weakly detected-1, or strongly detected-2.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The Spearman’s rank coefficient was calculated for operator-ranked results and graphs constructed in Graphpad Prism Version 9.0.2.
    Graphpad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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:
    Though an apparently relatively rare and a minor contributor to overall test performance in this and previous studies, false negative results in low Ct/high viral load samples may be significant in real-world contexts in which missing active infections can lead to preventable transmission events (although the clinical relevance of this remains to be seen, since RADT results correlate better with viral cultivability than PCR results (19-21)) In our opinion, this observation reveals an important limitation to use of RADTs for mass screening activities and also lends strong support to following an algorithm in which symptomatic RADT negative persons are re-tested (by RADT or preferably RT-PCR), as is recommended by the WHO (1). Indeed, previous evaluations of RADT accuracy in asymptomatic groups, such as children (24) and household contacts of known cases (25) have reported low sensitivity of the Panbio™ in these populations, probably due to low viral load (high Ct value). In previous analyses the Panbio™ test LOD has been described as correspondent to a Ct value of between 24 and 29 (10-18). Our LOD results using sample serial dilution were consistent with these published LODs, since we estimate the LOD as between approximate Ct 28 and 32, as there was a weak line detected in a sample with Ct 28 but no line at Ct 32 (Figure 2A). In addition, blinded operator-ranked results of RADT signal intensity were significantly inversely correlated in the nonparametric analysis to sample C...

    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

    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 10.1101/2021.07.13.21260402v1 on medRxiv