Laboratory and field evaluation of the STANDARD Q and Panbio™ SARS-CoV-2 antigen rapid test in Namibia using nasopharyngeal samples

  1. Iyaloo Konstantinus
  2. Douglas Chiwara
  3. Emmy-Else Ndevaetela
  4. Victoria Ndarukwa-Phiri
  5. Nathalia! Garus-oas
  6. Ndahafa Frans
  7. Pentikainen Ndumbu
  8. Andreas Shiningavamwe
  9. Gerhard van Rooyen
  10. Ferlin Schiceya
  11. Lindile Hlahla
  12. Pendapala Namundjebo
  13. Ifeoma Ndozi-Okia
  14. Francis Chikuse
  15. Sirak Hailu Bantiewalu
  16. Kapena Tjombonde

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

As new SARS-CoV-2 variants of concern emerge, there is a need to scale up testing to minimize transmission of the Coronavirus disease 2019 (COVID-19). Many countries especially those in the developing world continue to struggle with scaling up reverse transcriptase polymerase reaction (RT-PCR) to detect SARS-CoV-2 due to scarcity of resources. Alternatives such as antigen rapid diagnostics tests (Ag-RDTs) may provide a solution to enable countries scale up testing.

Methods

In this study, we evaluated the Panbio ™ and STANDARD Q Ag-RDTs in the laboratory using 80 COVID-19 RT-PCR confirmed and 80 negative nasopharyngeal swabs. The STANDARD Q was further evaluated in the field on 112 symptomatic and 61 asymptomatic participants.

Results

For the laboratory evaluation, both tests had a sensitivity above 80% (Panbio ™ = 86% vs STANDARD Q = 88%). The specificity of the Panbio ™ was 100%, while that of the STANDARD Q was 99%. When evaluated in the field, the STANDARD Q maintained a high specificity of 99%, however the sensitivity was reduced to 56%.

Conclusion

Using Ag-RDTs in low resource settings will be helpful in scaling-up SARS-CoV-2 testing, however, negative results should be confirmed by RT-PCR where possible to rule out COVID-19 infection.

Article activity feed

  1. Version published to 10.1371/journal.pone.0269329
  2. ScreenIT

    SciScore for 10.1101/2021.09.21.21263886: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This evaluation was approved by the research ethics committee of the Ministry of Health and Social Services (Ref:17/3/3/EEN).
    Field Sample Permit: RT-PCR and Ag-RDT testing: Nasopharyngeal swabs collected in viral transport medium (VTM) were processed within 24 hours of collection.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Study design and population: The laboratory evaluation was a cross-sectional, retrospective verification of the performance of the STANDARD Q (SD Biosensor, Republic of Korea) and Panbio™ (Abbott Diagnostic GmbH).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Mann-Whitney U test was computed to compare the differences between two groups using Prism V9 (GraphPad Software).
    Prism
    suggested: (PRISM, RRID:SCR_005375)
    GraphPad
    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:
    One of the limitations for this study included the credibility of the symptom onset of the participants included in the field of evaluation. We could not determine with certainty whether the samples collected were from patients whose symptoms onset was within 5-7 days. This is important because these tests have been reported to be more reliable in detecting SARS-CoV-2 infection within the first 7 days after the onset of symptoms. Therefore, they can miss individuals who are in the very early stage of infection (presymptomatic stage) and those who are in the late stage with a decreased viral replication. In conclusion, these results add to the body of evidence that Ag-RDTs are useful and may be utilized to scale up testing to reduce viral transmission in settings where RT-PCR is a challenge.

    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.

  3. Version published to 10.1101/2021.09.21.21263886v1 on medRxiv