Han Lee Goh
Email Address
entghl@nus.edu.sg
Organizational Units
YONG LOO LIN SCH OF MEDICINE
faculty
OTOLARYNGOLOGY
dept
2 results
Publication Search Results
Now showing 1 - 2 of 2
Publication Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing(SPRINGER LONDON LTD, 2021-01-11) Tay, Joshua K; Cross, Gail B; Sun, Louisa; Chia, Alfred; Chee, Jeremy; Loh, Jerold; Lim, Zhenyu; Ngiam, Nicholas; Khang, WenPang; Yeap, Stephanie; Goh, Han Lee; Siow, Chor Hiang; Loh, WoeiShyang; Loh, KwokSeng; Lee, ChunKiat; Yan, Benedict; Chow, Vincent TK; Wang, De Yun; Boey, Freddy; Wong, John EL; Allen, David M; Assoc Prof David Michael Allen; BIOMEDICAL ENGINEERING; MEDICINE; MICROBIOLOGY AND IMMUNOLOGY; OTOLARYNGOLOGYIntroduction: The gold standard for COVID-19 diagnosis is currently a real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect SARS-CoV-2. This is most commonly performed on respiratory secretions obtained via a nasopharyngeal swab. Due to supply chain limitations and high demand worldwide because of the COVID-19 pandemic, access to commercial nasopharyngeal swabs has not been assured. 3D printing methods have been used to meet the shortfall. For longer-term considerations, 3D printing may not compare well with injection molding as a production method due to the challenging scalability and greater production costs of 3D printing. Methods: To secure sufficient nasopharyngeal swab availability for our national healthcare system, we designed a novel injection molded nasopharyngeal swab (the IM2 swab). We performed a clinical diagnostic study comparing the IM2 swab to the Copan FLOQSwab. Forty patients with a known diagnosis of COVID-19 and 10 healthy controls were recruited. Paired nasopharyngeal swabs were obtained from the same nostril of each participant and tested for SARS-CoV-2 by RT-PCR. Results: When compared to the Copan FLOQswab, results from the IM2 swab displayed excellent overall agreement and positive percent agreement of 96.0% and 94.9%, respectively. There was no significant difference in mean RT-PCR cycle threshold values for the ORF1ab (28.05 vs. 28.03, p = 0.97) and E-gene (29.72 vs. 29.37, p = 0.64) targets, respectively. We did not observe any significant adverse events and there was no significant difference in patient-reported pain. Conclusion: In summary, the IM2 nasopharyngeal swab is a clinically safe, highly accurate option to commercial nasopharyngeal swabs.Publication Design and Multicenter Clinical Validation of a 3-Dimensionally Printed Nasopharyngeal Swab for SARS-CoV-2 Testing(AMER MEDICAL ASSOC, 2021-02-18) 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; Assoc Prof David Michael Allen; DEAN'S OFFICE (SCALE); DIVISION OF INDUSTRIAL DESIGN; MEDICINE; MICROBIOLOGY AND IMMUNOLOGY; DEAN'S OFFICE (ENGINEERING); MECHANICAL ENGINEERING; OTOLARYNGOLOGY; DUKE-NUS MEDICAL SCHOOLImportance: 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.