Validation of the Panbio™ COVID-19 Antigen Rapid Test (Abbott) to screen for SARS-CoV-2 infection in Sint Maarten: a diagnostic accuracy study

  1. Colin King
  2. Eva Lista-de Weever
  3. Maria Henry
  4. Radjin Steingrover
  5. Chérina Fleming
  6. Richard Panneflek
  7. Sanne van Kampen

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Abstract

Objectives

Control of the pandemic has required countries to look for other forms of tests besides the gold standard real-time polymerase chain reaction (RT-PCR). Rapid antigen tests (RAT), though less sensitive than RT-PCR, offer the possibility of rapid, inexpensive and early detection of the most infectious COVID-19 cases. Only very few studies have assessed the performance of the Abbott Panbio COVID-19 RAT among asymptomatic people or in Latin America. This study set out to validate this test among people attending the public test street in Sint Maarten, Dutch Caribbean.

Methods

People of all ages were recruited from the public COVID-19 test street regardless of COVID-19 symptoms. They received a nasopharyngeal swab for the Abbott Panbio COVID-19 RAT and the RT-PCR Qtower. Diagnostic accuracy of the RAT was compared to the RT-PCR among the overall study population and for subgroups with/without symptoms, with/without close contact and different Ct values.

Results

Using a RT-PCR Ct cut-off value of <33, 119 out of 1,411 people (8.4%) tested positive for SARS-CoV-2. Most were asymptomatic (59%). The overall sensitivity and specificity of the RAT was 84% (95% CI 76.2-90.1) and 99.9% (95% CI 99.6-100) respectively. The sensitivity reduced to 67.6% (95% CI: 49.5%, 82.6%) among people without symptoms, regardless of whether they were in close contact with a known COVID-19 case. Sensitivity reduced considerably with a Ct cut-off value of <35.

Conclusions

The Abbott Panbio RAT is a valid and cheaper alternative to RT-PCR when used on symptomatic individuals among the general population. However, among asymptomatic people it should not be used as a stand-alone test and negative results should be confirmed with RT-PCR.

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  3. ScreenIT

    SciScore for 10.1101/2021.09.23.21260526: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All persons were given verbal information about the testing procedure and were asked for consent to participate in the study.
    IRB: Ethical approval: Ethical approval was requested from the Sint Maarten Medical Center (SMMC) Medical Ethics Committee, who decided that ethical oversight was not required for this study.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisSample size calculation: Based on Buderer et al.,9 a minimal required sample size was calculated to accurately estimate the sensitivity and specificity of the RAT with a significance level of 5%.
    Cell Line AuthenticationAuthentication: This test fits the WHO criteria (sensitivity of ≥80%, specificity of ≥97%) 8 and has been validated in the Netherlands among symptomatic persons.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical calculations were performed in Stata and SPSS.
    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:
    One limitation of this study was that it was unable to follow up persons before or after their test result. It is thus unknown whether PCR-positive persons were in the early or late stage of their infection and how the Abbott RAT performed in identifying people in their most contagious period. Further, symptoms were self-reported and may have been over-or underreported, which could have biased the difference in sensitivity between symptomatic and asymptomatic individuals. One main implication of this study is that the Abbott RAT is not beneficial as a stand-alone test for asymptomatic people as it will miss approximately one out of three people with COVID-19 in this subgroup. The results show that approximately one out of ten positive individuals with symptoms will not be spotted with the RAT, which makes it an acceptable alternative for this subgroup. These findings confirm that COVID-19 RATs perform better among people with higher viral loads.15 Based on these findings, the public health authorities in Sint Maarten decided to perform the Abbott Panbio RAT among symptomatic people only, while remaining to test all people attending the test street regardless of symptoms with RT-PCR. In conclusion, the Abbott Panbio RAT is a valid and cheaper alternative to RT-PCR for detecting COVID-19 when used on symptomatic individuals among the general population. Taking into consideration the low cost, user-friendliness, and turnaround time, this test would also be beneficial to identify...

    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.

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  4. Version published to 10.1101/2021.09.23.21260526v1 on medRxiv