Creating SARS-CoV-2 (COVID-19) Sample Collection Test Kits

Study: The rapid transmission of COVID-19 exceeded the availability of commercially produced detection methods. An interdisciplinary collaboration was organized to identify, validate, and implement a component fabrication and assembly process for sample collection test kits used to detect COVID-19 by RT-PCR analysis to meet clinical and research needs at the University of Louisville. Methods: A review of commercial kits determined six components were needed: (1 & 2) a 6"x9" biohazard bag with a document pouch was use for the kit container and sample transport bag, (3) instructions for use (reviewed by public health nurses) were printed on stickers and adhered to the biohazard bag, (4) a sterile 15 mL centrifuge vial with a sealed cap was used for the sample vial, (5) sterile viral transport media prepared from a CDC recipe was dispensed into the vials, and (6) a sterile nasopharyngeal swab (FDA Class 1 device) with a domed, open lattice tip designed in Autodesk Fusion 360 and printed from Envisiontec E1 guide soft material resin by direct light projection on a NewPro1 3D printer. Every swab was inspected for defects. Accepted swabs were packaged and sterilized using steam autoclave. Swab efficacy was validated in a cohort prospective clinical study of 30 non-consecutive patients and healthcare workers with paired samples taken with commercial and 3D printed swabs. With confirmation of agreement between the swab types, production of test kits with 3D printed swabs began. Results: It was determined that 350 swabs could be made per print run with two print runs possible daily. The swab inspection acceptance rate was 80-85%. Test kit assembly rates of 600 to 1000 kits/day were achieved with costs ($3.50) ≤ commercial kits. Clinical comparison of swab types found 90% agreement, 89% sensitivity, and 92% specificity. Feedback from kit users was acceptable with over 11,500 kits distributed for use to date. This rapid, collaborative development process provided effective sampling test kits to support COVID-19 research and clinical screening.