• Summer J Decker, Todd A Goldstein, Jonathan M Ford, Michael N Teng, Robert S Pugliese, Gregory J Berry, Matthew Pettengill, Suzane Silbert, Todd R Hazelton, Jason W Wilson, Kristy Shine, Zi-Xuan Wang, Morgan Hutchinson, Joseph Castagnaro, Ona E Bloom, Dwayne A Breining, Barbara M Goldsmith, John T Sinnott, Donna Gentile O'Donnell, James M Crawford, Charles J Lockwood, and Kami Kim.
• University of South Florida, Morsani College of Medicine, Tampa, Florida, USA.
• Clin. Infect. Dis. 2021 Nov 2; 73 (9): e3027-e3032.

BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), can be detected in respiratory samples by real-time reverse transcriptase polymerase chain reaction (RT-PCR) or other molecular methods. Accessibility of diagnostic testing for COVID-19 has been limited by intermittent shortages of supplies required for testing, including flocked nasopharyngeal (FLNP) swabs.MethodsWe developed a 3-dimensional printed nasopharyngeal (3DP) swab as a replacement of the FLNP swab. The performance of 3DP and FLNP swabs were compared in a clinical trial of symptomatic patients at 3 clinical sites (n = 291) using 3 SARS-CoV-2 emergency use authorization tests: a modified version of the Centers for Disease Control and Prevention (CDC) RT-PCR Diagnostic Panel and 2 commercial automated formats, Roche Cobas and NeuMoDx.ResultsThe cycle threshold-C(t)-values from the gene targets and the RNase P gene control in the CDC assay showed no significant differences between swabs for both gene targets (P = .152 and P = .092), with the RNase P target performing significantly better in the 3DP swabs (P < .001). The C(t) values showed no significant differences between swabs for both viral gene targets in the Roche cobas assay (P = .05 and P = .05) as well as the NeuMoDx assay (P = .401 and P = .484). The overall clinical correlation of COVID-19 diagnosis between all methods was 95.88% (Kappa 0.901).ConclusionsThe 3DP swabs were equivalent to standard FLNP in 3 testing platforms for SARS-CoV-2. Given the need for widespread testing, 3DP swabs printed onsite are an alternate to FLNP that can rapidly scale in response to acute needs when supply chain disruptions affect availability of collection kits.© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

12 keywords...

hide…