Rapid Open Development and Clinical Validation of Multiple New 3D-Printed Nasopharyngeal Swabs in Response to the COVID-19 Pandemic

ABSTRACT Background The SARS-CoV-2 pandemic has caused a severe international shortage of the nasopharyngeal (NP) swabs required for testing. We participated in an unprecedentedly open and urgent iterative process to help develop and validate new swabs. Methods We tested prototypes for material suitability, collection sufficiency, PCR compatibility, and the likelihood that they could be mass-produced, individually packaged, and sterilized quickly. Suitable prototypes were selected for an ongoing IRB-approved clinical trial. Participants were outpatients suspected of COVID-19 who presented to our drive-through test station. Each participant was swabbed with a control swab followed by a prototype swab. For each prototype, at least 10 control-swab positive and 10 control-swab negative PCR results were collected. We measured concordance using Cohen9s kappa, compared Ct values by Mann-Whitney U, and assessed staff preferences via written survey. Results We evaluated 45 materials and 150 designs from 23 individuals, laboratories, and companies. We have selected four so far for the clinical trial. Three have completed testing. For these, we obtained PCR results from control and prototype swabs from 230 people (74-79 pairs/prototype). Concordance was 0.85-0.89 on 10-19 control-swab positives and 58-67 control-swab negatives. Ct values were statistically indistinguishable from controls. Staff preferred two of the prototypes over the third but ultimately preferred the control swab most. The time elapsed between identification of the problem and development of a high-manufacturing-volume solution was three weeks. Conclusions Our experience provides lessons for how an open process can efficiently and effectively contribute to resolving a medical manufacturing crisis during a major pandemic. Trial registration number Beth Israel Deaconess Medical Center (BIDMC) Institutional Review Board (IRB) Protocol 2020P000323