• Joshua K Tay, Gail B Cross, Louisa Sun, Alfred Chia, Jeremy Chee, Jerold Loh, Zhen Yu Lim, Nicholas Ngiam, Wen Pang Khang, Stephanie Yeap, Han Lee Goh, Chor Hiang Siow, Woei Shyang Loh, Kwok Seng Loh, Chun Kiat Lee, Benedict Yan, ChowVincent T KVTKDepartment of Microbiology and Immunology, National University of Singapore, Singapore, Singapore., WangDe YunYDepartment of Otolaryngology-Head and Neck Surgery, National University of Singapore, Singapore, Singapore., Freddy Boey, WongJohn E LJELDepartment of Medicine, National University of Singapore, Singapore, Singapore.Department of Hematology-Oncology, National University Cancer Institute, Singapore, Singapore., and David M Allen.
• Department of Otolaryngology-Head and Neck Surgery, National University of Singapore, Singapore, Singapore.
• Infect Dis Ther. 2021 Jun 1; 10 (2): 1015-1022.

IntroductionThe 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.MethodsTo 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.ResultsWhen 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.ConclusionIn summary, the IM2 nasopharyngeal swab is a clinically safe, highly accurate option to commercial nasopharyngeal swabs.

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