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Title: Design and Multicenter Clinical Validation of a 3-Dimensionally Printed Nasopharyngeal Swab for SARS-CoV-2 Testing
Authors: Tay, Joshua K
Cross, Gail B 
Toh, Song Tar
Lee, Chun Kiat
Loh, Jerold
Lim, Zhen Yu
Ngiam, Nicholas
Chee, Jeremy
Gan, Soo Wah 
Saraf, Anmol 
Chow, Wai Tung Eason
Goh, Han Lee 
Siow, Chor Hiang 
Lian, Derrick WQ
Loh, Woei Shyang 
Loh, Kwok Seng
Lim, Chwee Ming
Chua, Ying Ying 
Tan, Thuan Tong
Tan, Hiang Khoon 
Yan, Benedict
Ko, Karrie
Chan, Kian Sing 
Oon, Lynette
Chow, Vincent TK 
Wang, De Yun 
Fuh, Jerry YH 
Yen, Ching-Chiuan 
Wong, John EL
Allen, David M 
Keywords: Science & Technology
Life Sciences & Biomedicine
Issue Date: 18-Feb-2021
Citation: Tay, Joshua K, Cross, Gail B, Toh, Song Tar, Lee, Chun Kiat, Loh, Jerold, Lim, Zhen Yu, Ngiam, Nicholas, Chee, Jeremy, Gan, Soo Wah, Saraf, Anmol, Chow, Wai Tung Eason, Goh, Han Lee, Siow, Chor Hiang, Lian, Derrick WQ, Loh, Woei Shyang, Loh, Kwok Seng, Lim, Chwee Ming, Chua, Ying Ying, Tan, Thuan Tong, Tan, Hiang Khoon, Yan, Benedict, Ko, Karrie, Chan, Kian Sing, Oon, Lynette, Chow, Vincent TK, Wang, De Yun, Fuh, Jerry YH, Yen, Ching-Chiuan, Wong, John EL, Allen, David M (2021-02-18). Design and Multicenter Clinical Validation of a 3-Dimensionally Printed Nasopharyngeal Swab for SARS-CoV-2 Testing. JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY 147 (5) : 418-425. ScholarBank@NUS Repository.
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.
ISSN: 21686181
DOI: 10.1001/jamaoto.2020.5680
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