Clinical testing was done to quantifying the sensitivity and specificity of the 3D printed swab and locally produced UTM kit compared to the commercially available kits (FLOQSwab by COPAN Diagnostics™ Murrieta, USA; CITISWAB by Citotest Scientific™ Jiangsu, P.R. China) on consecutive COVID-19 positive and negative patients at Jaber Al-Ahmad Al-Sabah Hospital Kuwait from April 27, 2020 until May 19, 2020. After informed consent, patients aged 21 and above who were scheduled for nasopharyngeal swabbing were tested using the commercial kits first, and shortly after, swabbed again by the same health care worker in the alternate nostril using the 3D printed swab and locally produced UTM kit. A survey was filled with each 3D printed swab kit to assess the patient comfort, swab collectors’ experience using the swab, as well as recording any adverse events. In addition, ten “ghost” swabs, where no patient was actually swabbed, from the 3D printed swab batch were sent to the lab as anonymous specimens to test for false positive results.
Both commercial and 3D printed specimens were sent to a single virology laboratory, where testing using Tib MolBiol’s LightMix Real-Time Reverse Transcription PCR Kit (Roche™ Basel, Switzerland) was carried out.