SafeSwab, a sample collection and dispensing device for near-patient testing

Abstract Background The COVID-19 pandemic has accelerated the pace of innovation around virtual care visits and testing technology. Here we present the SafeSwab (Safe Health Systems, Los Angeles, CA), an integrated, universal sample collection and dispensing device that is designed to minimize user error and enable rapid testing in a point of care or self-testing format. Methods The SafeSwab was used with the Safe Health Systems HealthCheck digital health application to enable self-testing by patients using lateral flow tests for SARS-CoV-2 antigen or for antibodies against SARS-CoV-2. Results Patients (n=74) using the SafeSwab produced a valid rapid test result in 96% of attempts, and 96% of patients felt confident that they had collected a good sample. The Safe HealthCheck app has an integrated image analysis algorithm, AutoAdapt LFA, that interprets a picture of a rapid test result, and the algorithm interpreted the result correctly 100% of the time. Conclusion The SafeSwab was found to be versatile and easy to use for both self-collected nasal sampling as well as fingerstick blood sampling. The use of Safe Health Systems HealthCheck app allows an integrated solution for patient instruction and test interpretation