Evaluation of a Self-testing Rapid Diagnostic Test Device for Detecting SARS-CoV-2 in Oral Fluid

ABSTRACT

Objective: The aim of this evaluation report was to explore the reliability and performance of the All Test COVID-19 Antigen Rapid Test for Self-Testing (Oral Fluid) on clinical specimens collected for SARS-CoV-2 diagnosis and compared to a laboratory run RT-qPCR (real-time reverse transcription polymerase chain reaction) test. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for coronavirus disease 2019, which emerged as a novel human pathogen at the end of 2019. Since its emergence nearly two years ago, the virus has caused more than 257 million confirmed cases and has led to more than 5 million deaths globally as of November 22, 2021 [2]. [...]specimens need to be transported to and examined at sites that have RT-qPCR capability, which delays the test result and increases the anxiety of the suspected COVID-19 patients. Antigen tests are also important in the overall response against COIVD-19 as they can generally be produced at a lower cost than PCR tests and help public health officials better identify infection rates closer to real time.