Validation of an At-Home Direct Antigen Rapid Test for COVID-19

Abstract

This cohort study examines the performance of direct antigen rapid tests compared with that of quantitative real-time polymerase chain reaction for analyzing self-collected nasal specimens for the presence of SARS-CoV-2.

Conflict of interest statement

Conflict of Interest Disclosures: Ms Salcedo, Ms Sena, and Dr Herrera are employed by and have a financial interest in E25Bio, Inc, a biotechnology company that develops rapid tests for infectious diseases. At the time of the study, Mr Harmon and Dr Bosch were employed by E25Bio, Inc, and have a financial interest in the company. No other disclosures were reported.

Figures

Figure.. Longitudinal Analysis of SARS-CoV-2 Nucleocapsid and Viral Genome Levels

Graphs show longitudinal analysis of SARS-CoV-2 nucleocapsid and viral genome levels using an at-home, semiquantitative direct antigen rapid test (DART) and quantitative real-time polymerase chain reaction (qRT-PCR) for 15 positive participants. The orange lines represent the DART data for each individual, the dark blue lines represent the viral RNA target N1, and the light blue lines represents the viral target N2. The x-axis corresponds to number of days after first reported symptoms, with 0 indicating 1 day before symptoms onset. The left y-axis corresponds to background subtracted DART signal normalized to the control line for each test. The right y-axis corresponds to the cycle threshold of viral RNA targets N1 and N2 in each sample. DART results less than 10% of control are considered negative results, which is indicated by the orange dashed line.