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. 2020 Sep 10:ciaa1366. doi: 10.1093/cid/ciaa1366

3D Printed Alternative to the Standard Synthetic Flocked Nasopharyngeal Swabs Used for COVID-19 testing

Summer J Decker 1,, Todd A Goldstein 2, Jonathan M Ford 1, Michael N Teng 1, Robert S Pugliese 3, Gregory J Berry 2,4, Matthew Pettengill 5, Suzane Silbert 6, Todd R Hazelton 1, Jason W Wilson 1, Kristy Shine 7, Zi-Xuan Wang 5, Morgan Hutchinson 7, Joseph Castagnaro 2, Ona E Bloom 2, Dwayne A Breining 2,4, Barbara M Goldsmith 5, John T Sinnott 1, Donna Gentile O'Donnell 3, James M Crawford 2,4, Charles J Lockwood 1, Kami Kim 1
PMCID: PMC7499529  PMID: 32910817

Abstract

Background

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, can be detected in respiratory samples by Real-time Reverse Transcriptase (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.

Methods

We developed a 3D-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 three clinical sites (n=291) using three SARS-CoV-2 EUA tests: a modified version of the CDC Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel and two commercial automated formats, Roche Cobas and NeuMoDx.

Results

The 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=0.152 and p=0.092), with the RNase P target performing significantly better in the 3DP swabs (p & 0.001). The C(t) values showed no significant differences between swabs for both viral gene targets in the Roche cobas assay (p=0.05 and p=0.05) as well as the NeuMoDx assay (p=0.401 and p=0.484). The overall clinical correlation of COVID-19 diagnosis between all methods was 95.88% (Kappa 0.901).

Conclusions

3DP swabs were equivalent to standard FLNP in three testing platforms for SARS-CoV-2. Given the need for widespread testing, 3DP swabs printed on-site are an alternate to FLNP that can rapidly scale in response to acute needs when supply chain disruptions affect availability of collection kits.

Keywords: SARS-CoV-2, COVID-19, 3D-printed swabs, molecular diagnostics, nasopharyngeal


Articles from Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America are provided here courtesy of Oxford University Press

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