Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2

  1. Chiara E. Ghezzi
  2. Devon R. Hartigan
  3. Justin P. Hardick
  4. Rebecca Gore
  5. Miryam Adelfio
  6. Anyelo R. Diaz
  7. Pamela D. McGuinness
  8. Matthew L. Robinson
  9. Bryan O. Buchholz
  10. Yukari C. Manabe

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Abstract

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

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  1. Version published to 10.3390/diagnostics12010206
  2. ScreenIT

    SciScore for 10.1101/2021.10.19.21265200: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This study was reviewed and approved by the institutional review board of UML (protocol number 20-149-BUC-FUL). 1.2. Participants: Participants were healthy individuals, as self-reported and determined by a screening asked during recruitment consent, and already enrolled into the surveillance program at UML.
    Consent: Adults over 18 years of age were given an informed consent form by study staff and asked whether they would agree to being swabbed with an experimental swab by a trained nurse to the control swab required for testing.
    Sex as a biological variablenot detected.
    RandomizationThey were all tested first with NP swabs and then randomly swabbed nasally first with the ClearTip™ N swab or commercially available comparator (Copan).
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Paired t-test, equivalence tests and the weighted generalized score method were analyzed using SAS 9.4 (SAS Institute, Inc.
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)
    Additional Student’s T-test (T-test) with a p-value of < 0.05 was performed with Origin(Pro), Version 2021b OriginLab Corporation, Northampton, MA, USA.
    OriginLab Corporation
    suggested: (Origin, RRID:SCR_014212)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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 10.1101/2021.10.19.21265200v1 on medRxiv