An Assessment of a Rapid SARS-CoV-2 Antigen Test in Bangladesh

  1. Zannat Kawser
  2. Mohabbat Hossain
  3. Sara Suliman
  4. Shahin Lockman
  5. Jesse Gitaka
  6. Gama Bandawe
  7. Redwan Rahmat
  8. Imrul Hasan
  9. Abu Bakar Siddik
  10. Mokibul Hassan Afrad
  11. Mohammed Ziaur Rahman
  12. Glenn Miller
  13. David R. Walt
  14. Louise C. Ivers
  15. Regina C. LaRocque
  16. Jason B. Harris
  17. Firdausi Qadri

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Abstract

Early detection of SARS-CoV-2 infection is crucial to prevent its spread. This study aimed to document test sensitivity/specificity, correlation with cycle threshold value from polymerase chain reaction (PCR), fitness-for-use in different populations and settings, and user perspectives that could inform large-scale implementation. In this study, we evaluated the performance of a rapid antigen detection test, BD Veritor, and compared this (and another rapid test, Standard Q) against reverse transcription PCR (RT-PCR) in terms of sensitivity and specificity in 130 symptomatic and 130 asymptomatic adults. In addition, we evaluated the suitability and ease of use of the BD Veritor test in a subsample of study participants ( n = 42) and implementers ( n = 5). At 95% confidence interval, the sensitivity of the BD Veritor and Standard Q test were 70% and 63% in symptomatic and 87% and 73% in asymptomatic individuals, respectively, regarding positive SARS-CoV-2 RT-PCR results. Overall, the BD Veritor test was 78% sensitive and 99.5% specific compared with RT-PCR irrespective of the cycle threshold. This warrants large field evaluation as well as use of the rapid antigen test for quick assessment of SARS-CoV-2 for containment of epidemics in the country.

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  1. Version published to 10.4269/ajtmh.22-0068
  2. ScreenIT

    SciScore for 10.1101/2021.10.05.21264551: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Written informed consent was obtained from participants.
    IRB: The study was approved by the Research Review Committee (RRC) and Ethical Review Committee (ERC) of icddr,b (Protocol no: PR-20042).
    IACUC: The study was approved by the Research Review Committee (RRC) and Ethical Review Committee (ERC) of icddr,b (Protocol no: PR-20042).
    Field Sample Permit: Specimen collection: Nasopharyngeal swab specimens were collected by trained personnel and placed in a 3-mL tube of viral transport medium (Citoswab, Citotest
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: Specimens were determined to be positive for SARS-CoV-2 when the ORF1ab and N genes were detected with an exponential growth curve and a cycle threshold (Ct) value <40, and negative when these genes could not be detected.

    Table 2: Resources

    No key resources detected.

    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 is that we compared rapid antigen tests that required different types of clinical specimens: For the BD Veritor we used anterior nares specimens for rapid test and a NP sample for PCR; the Standard Q uses only one nasopharyngeal specimen, which is diluted in viral transport media and used for both PCR and rapid test. If the concentration of the virus differs between AN and NP swabs, that is in the two sites of the nostril, it can also affect results. However, we did not see significant discrepancies between the two tests, except when specimens had high RT-PCR Ct values, indicating low viral loads. In that case both BD Veritor and the Standard Q failed to detect SARS-CoV-2 virus. Notably, we also found the BD Veritor rapid antigen test to be more sensitive even though the anterior nares specimen for it were collected later for the RT-PCR positive individuals. Our study on rapid antigen tests is timely for Bangladesh which is currently experiencing a second wave and high rates of COVID-19 (16). Point of care tests are urgently needed for health facilities, travelers, workplaces and the general population, and our findings can help guide the implementation of these tests in Bangladesh. The BD Veritor test is sensitive enough to detect cases with high viral load in pre-symptomatic and early symptomatic cases as well as asymptomatic persons – groups that likely contribute to a significant proportion of transmission and spread of the disease (17). The pati...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

    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.

  3. Version published to 10.1101/2021.10.05.21264551 on medRxiv