Design and Multicenter Clinical Validation of a 3-Dimensionally Printed Nasopharyngeal Swab for SARS-CoV-2 Testing | Infectious Diseases | JAMA Otolaryngology–Head & Neck Surgery | JAMA Network
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    Original Investigation
    February 18, 2021

    Design and Multicenter Clinical Validation of a 3-Dimensionally Printed Nasopharyngeal Swab for SARS-CoV-2 Testing

    Author Affiliations
    • 1Department of Otolaryngology–Head and Neck Surgery, National University of Singapore, Singapore
    • 2Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore
    • 3Department of Medicine, National University of Singapore, Singapore
    • 4Department of Otolaryngology–Head and Neck Surgery, Singapore General Hospital, Singapore
    • 5Molecular Diagnostic Centre, Department of Laboratory Medicine, National University Hospital, Singapore
    • 6Centre for Additive Manufacturing, National University of Singapore, Singapore
    • 7Keio-NUS CUTE Center, National University of Singapore, Singapore
    • 8Department of Pathology, National University of Singapore, Singapore
    • 9Department of Infectious Diseases, Singapore General Hospital, Singapore
    • 10Division of Surgery and Surgical Oncology, Singapore General Hospital and National Cancer Centre, Singapore
    • 11Department of Laboratory Medicine, Singapore General Hospital, Singapore
    • 12Department of Microbiology and Immunology, National University of Singapore, Singapore
    • 13Department of Mechanical Engineering, National University of Singapore, Singapore
    • 14Division of Industrial Design, National University of Singapore, Singapore
    • 15Department of Hematology-Oncology, National University Cancer Institute, Singapore
    JAMA Otolaryngol Head Neck Surg. Published online February 18, 2021. doi:10.1001/jamaoto.2020.5680
    Key Points

    Question  Is a novel 3-dimensionally printed nasopharyngeal swab (3DP swab) accurate in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)?

    Findings  In this diagnostic study for coronavirus disease 2019 (COVID-19) across 2 institutions of 79 patients with COVID-19 and 10 controls, the overall agreement and positive percentage agreement of the 3DP swab was 91.1% and 93.5%, respectively, compared with the traditional FLOQSwab (COPAN Diagnostics) and Dacron swab (Deltalab). The positive percentage agreement was 100% for COVID-19 cases tested within the first week of illness, and reverse-transcriptase polymerase chain reaction cycle threshold values for the ORF1ab and E-gene targets showed a strong correlation between the 3DP and traditional swab on independent testing at each institution despite differences in sample processing.

    Meaning  The 3DP swab performed accurately and consistently across health care institutions and may help mitigate strained resources in the escalating COVID-19 pandemic..

    Abstract

    Importance  Three-dimensionally printed nasopharyngeal swabs (3DP swabs) have been used to mitigate swab shortages during the coronavirus disease 2019 (COVID-19) pandemic. Clinical validation for diagnostic accuracy and consistency, as well as patient acceptability, is crucial to evaluate the swab’s performance.

    Objective  To determine the accuracy and acceptability of the 3DP swab for identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

    Design, Setting, and Participants  A diagnostic study was conducted from May to July 2020 at 2 tertiary care centers in Singapore with different reference swabs (FLOQSwab [COPAN Diagnostics] or Dacron swab [Deltalab]) and swab processing techniques (wet or dry) to evaluate the performance of the 3DP swab compared with traditional, standard-of-care nasopharyngeal swabs used in health care institutions. The participants were patients with COVID-19 in the first 2 weeks of illness and controls with acute respiratory illness with negative test results for SARS-CoV-2. Paired nasopharyngeal swabs were obtained from the same nostril and tested for SARS-CoV-2 by reverse-transcriptase polymerase chain reaction. The sequence of swabs was randomized based on odd and even participant numbers.

    Main Outcomes and Measures  Primary outcome measures were overall agreement (OA), positive percentage agreement (PPA), and negative percentage agreement of the 3DP swab compared with reference swabs. Secondary outcome measures were the correlation of cycle threshold (Ct) values of both swabs.

    Results  The mean (SD) age of participants was 45.4 (13.1) years, and most participants were men (87 of 89 [97.8%]), in keeping with the epidemiology of the COVID-19 pandemic in Singapore. A total of 79 patients with COVID-19 and 10 controls were recruited. Among the patients with COVID-19, the overall agreement and PPA of the 3DP swab was 91.1% and 93.5%, respectively, compared with reference swabs. The PPA was 100% for patients with COVID-19 who were tested within the first week of illness. All controls tested negative. The reverse-transcriptase polymerase chain reaction Ct values for the ORF1ab and E-gene targets showed a strong correlation (intraclass correlations coefficient, 0.869-0.920) between the 3DP and reference swab on independent testing at each institution despite differences in sample processing. Discordant results for both gene targets were observed only at high Ct values.

    Conclusions and Relevance  In this diagnostic study of 79 patients with COVID-19 and 10 controls, the 3DP swab performed accurately and consistently across health care institutions and could help mitigate strained resources in the escalating COVID-19 pandemic.

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