Abstract
3D-printed alternatives to standard flocked swabs were rapidly developed to provide a response to the unprecedented and sudden need for an exponentially growing amount of diagnostic tools to fight the COVID-19 pandemic. In light of the anticipated shortage, a hospital-based 3D-printing platform was implemented in our institution for the production of swabs for nasopharyngeal and oropharyngeal sampling based on the freely available, open-source design provided to the community by University of South Florida’s Health Radiology and Northwell Health System teams as a replacement for locally used commercial swabs. Validation of our 3D-printed swabs was performed with a head-to-head diagnostic accuracy study of the 3D-printed “Northwell model” with the cobas PCR Media® swab sample kit. We observed an excellent concordance (total agreement 96.8%, Kappa 0.936) in results obtained with the 3D-printed and flocked swabs, indicating that the in-house 3D-printed swab could be used reliably in the context of a shortage of flocked swabs. To our knowledge, this is the first study to report on autonomous hospital-based production and clinical validation of 3D-printed swabs.
Highlights
On 11 March 2020, the World Health Organization (WHO) declared the coronavirus 19 disease (COVID-19) outbreak caused by the highly transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a global pandemic [1,2,3,4]
Efficiency of the sterilization was verified for each lot through inhibition of Geobacillus stearothermophilus spore suspension inoculated on the head of one swab per lot (Figure 2)
Previous clinical trials performed by the University of South Florida (USF) and Northwell Health System (NHS) teams reached similar conclusions by comparing the 3D-printed “USF model” swab with standard flocked swabs using alternative transport medium, including the WHO-approved viral transport media, media produced in-house according to the procedure described by the Centers for Disease Control and Prevention (CDC) or commercially available universal transport media [10]
Summary
On 11 March 2020, the World Health Organization (WHO) declared the coronavirus 19 disease (COVID-19) outbreak caused by the highly transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a global pandemic [1,2,3,4]. This triggered an unprecedented and sudden need for an exponentially growing amount of personal protection equipment and diagnostic tools. As typically performed for the detection of respiratory viruses, an accurate COVID-19 PCR assay relies on the collection of samples from the upper respiratory tract, including nasopharyngeal (NP) and oral mucosal surfaces [6]. As testing rapidly became critical for the development of a COVID-19 response strategy, the world encountered a shortage of PCR reagents and sampling swabs, resulting in testing backlogs, delayed diagnoses, compromised contact tracing and quarantine of patients, and potentially increased disease transmission
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