3D-printed Swabs Research Articles

Clinical validation of 3D-printed swabs in adults and children for SARS-CoV-2 detection.

Throughout the entire coronavirus disease 19 (COVID-19) pandemic, there were disruptions in the supply chain of test materials around the world, primarily in poor- and middle-income countries. The use of 3D prints is an alternative to address swab supply shortages. In this study, the feasibility of the clinical use of 3D-printed swabs for oropharyngeal and nasopharyngeal sampling for the detection of SARS-CoV-2 infection was evaluated. For that purpose, paired samples with the 3D printed and the control swabs were taken from 42 adult patients and 10 pediatric patients, and the results obtained in the detection of SARS-CoV-2 by reverse transcription and quantitative polymerase chain reaction (RT-qPCR) were compared. Additionally, in those cases where the result was positive for SARS-CoV-2, the viral load was calculated by means of a mathematical algorithm proposed by us. For both adults and children, satisfactory results were obtained in the detection of SARS-CoV-2 by RT-qPCR; no significant differences were found in the quantification cycle values between the 3D-printed swab samples and the control samples. Furthermore, we corroborated that the 3D-printed swabs caused less discomfort and pain at the time of sampling. In conclusion, this study shows the feasibility of routinely using 3D-printed swabs for both adults and children. In this way, it is possible to maintain local and cheaper consumption along with fewer distribution difficulties.

Validation of 3D-Printed Swabs for Sampling in SARS-CoV-2 Detection: A Pilot Study.

In this pilot study, we characterize and evaluate 3D-printed swabs for the collection of nasopharyngeal and oropharyngeal secretion samples for the SARS-CoV-2 detection. Swabs are made with the fused deposition modeling technique using the biopolymer polylactic acid (PLA) which is a medical-grade, biodegradable and low-cost material. We evaluated six swabs with mechanical tests in a laboratory and in an Adult Human Simulator performed by healthcare professionals. We proved the adequacy of the PLA swab to be used in the gold standard reverse transcriptase-polymerase chain reaction (qRT-PCR) for viral RNA detection. Then, we did in vitro validation for cell collection using the 3D-printed swabs and RNA extraction for samples from 10 healthy volunteers. The 3D-printed swabs showed good flexibility and maneuverability for sampling and at the same time robustness to pass into the posterior nasopharynx. The PLA did not interfere with the RNA extraction process and qRT-PCR test. When we evaluated the expression of the reference gene (RNase P) used in the SARS-CoV-2 detection, the 3D-printed swabs showed good reproducibility in the threshold cycle values (Ct = 23.5, range 19–26) that is comparable to control swabs (Ct = 24.7, range 20.8–32.6) with p value = 0.47. The 3D-printed swabs demonstrated to be a reliable, and an economical alternative for mass use in the detection of SARS-CoV-2.

3D-printed swab with cover for precision diagnosis

The collection capacity of common nasopharyngeal swabs and irregularities of medical personnel limit the accuracy of PCR testing. This study describes a newly designed 3D-printed swab that is combined with a 3D-printed cover to prevent the extraction of undesired nasal secretions. This swab improved the accuracy of PCR test results. The results of a series of experiments showed that, because of the mucus extraction effect, 3D-printed swabs can replace ordinary cotton swabs. The crisis of the worldwide medical supply shortage can be ameliorated to a certain extent by applying 3D printing technology.

Clinical Evaluation of In-House-Produced 3D-Printed Nasopharyngeal Swabs for COVID-19 Testing.

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.

Effective optimization of SARS-CoV-2 laboratory testing variables in an era of supply chain constraints.

RT-PCR-based assays for the detection of SARS-CoV-2 have played an essential role in the current COVID-19 pandemic. However, the sample collection and test reagents are in short supply, primarily due to supply chain issues. Thus, to eliminate testing constraints, we have optimized three key process variables: RNA extraction and RT-PCR reactions, different sample types and media to facilitate SARS-CoV-2 testing. By performing various validation and bridging studies, we have shown that various sample types such as nasopharyngeal swab, bronchioalveolar lavage and saliva, collected using conventional nasopharyngeal swabs, ESwab or 3D-printed swabs and, preserved in viral transport media, universal transport media, 0.9% sodium chloride or Amies media are compatible with RT-PCR assay for COVID-19. Besides, the reduction of PCR reagents by up to fourfold also produces reliable results.

Endoscopic removal of Fractured 3D-Printed Nasopharyngeal Swabs from the Olfactory Cleft During COVID-19

The severe acute respiratory syndrome SARS-CoV-2 pandemic has posed significant challenges to hospital and public health systems in the United States. In response to a shortage in nasopharyngeal swabs, our institution developed, tested, and deployed 3D-printed swabs to obtain a specimen for testing. A patient was tested in preparation for a scheduled Esophagogastrodeuodenoscopy. During the procedure the swab broke and a portion remained in the superior meatus and olfactory cleft. This case study describes the process of locating and removing the broken sections of the 3D-printed swab. In response to this incident, 3D-printing teams test swabs for sample collection and rheology with an elongation test. Additionally, we have implemented just-in-time training for staff including point-of-care durability testing, model simulation with feedback to ensure accurate trajectory, and suggestions on how to address anatomic and other challenges.