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 PARTICIPANTSA 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.
RESULTSThe 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 RELEVANCEIn 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.
The advent of new technologies in medical imaging and 3D printing in recent years has made customization of surgical tools and implants more accessible, revolutionizing many surgical fields. In many human diseases, these implants have led to superior surgical outcomes and greatly improved patients’ quality of life. Thus, it is of great interest to apply these technologies to the treatment of animal diseases. In this study, we report the use of computed tomography (CT) and 3D printing for the treatment of a Great Hornbill at Jurong Bird Park that was diagnosed with squamous cell carcinoma of the casque. A 3D printed prosthesis that perfectly fitted the subject was implanted to replace its resected casque. The subject exhibited natural eating behaviour with no post-operative complications. Using this case as an example, the positive outcomes suggest a great potential in applying these technologies to the treatment of other wildlife diseases.
We describe the development and validation of a novel 3D-printed nasopharyngeal swab for the identification of SARS-CoV-2. We subjected the novel swab to mechanical and fluid absorption testing ex-vivo, and confirmed its ability to retain and release murine coronavirus and SARS-CoV-2. Compared to the Copan FLOQSwab, the novel swab displayed excellent correlation of RT-PCR cycle threshold values on paired clinical testing in COVID-19 patients, at r = 0.918 and 0.943 for the SARS-CoV-2 ORF1/a and sarbecovirus E-gene respectively. Overall positive and negative percent agreement was 90.6% and 100% respectively on a dual-assay RT-PCR platform, with discordant samples observed only at high cycle thresholds. When carefully designed and tested, 3D-printed swabs are a viable alternative to traditional swabs and will help mitigate strained resources in the escalating COVID-19 pandemic.
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