Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test

• DOI: 10.1016/j.jcv.2021.104874
• Publication Date: 2021-05-29T06:46:43Z
• Authors: Andreas K. Lindner; Olga Nikolai; Chiara Rohardt; Franka Kausch; Mia Wintel; Maximilian Gertler; Susen Burock; Merle Hörig; Julian Bernhard; Frank Tobian; Mary Gaeddert; Federica Lainati; Victor M. Corman; Terry C. Jones; Jilian A. Sacks; Joachim Seybold; Claudia M. Denkinger; Frank P. Mockenhaupt
• Keywords: Adult; SARS-CoV-2; Self-swab; Short Communication; Antigen-detecting rapid diagnostic test; COVID-19; Self-testing; Sensitivity and Specificity; 3. Good health; 03 medical and health sciences; Self-Testing; 0302 clinical medicine; Feasibility Studies; Humans; RNA, Viral; Prospective Studies; Antigens, Viral

BACKGROUND: Considering the possibility of nasal self-sampling and the ease of use in performing SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs), self-testing is a feasible option. OBJECTIVE: The goal of this study was a head-to-head comparison of diagnostic accuracy of patient self-testing with professional testing using a SARS-CoV-2 Ag-RDT. STUDY DESIGN: We performed a manufacturer-independent, prospective diagnostic accuracy study of nasal mid-turbinate self-sampling and self-testing with symptomatic adults using a WHO-listed SARS-CoV-2 Ag-RDT. Procedures were observed without intervention. For comparison, Ag-RDTs with nasopharyngeal sampling were professionally performed. Estimates of agreement, sensitivity, and specificity relative to RT-PCR on a combined oro-/nasopharyngeal sample were calculated. Feasibility was evaluated by observer and participant questionnaires. RESULTS: Among 146 symptomatic adults, 40 (27.4%) were RT-PCR-positive for SARS-CoV-2. Sensitivity with self-testing was 82.5% (33/40; 95% CI 68.1-91.3), and 85.0% (34/40; 95% CI 70.9-92.9) with professional testing. At high viral load (≥7.0 log10 SARS-CoV-2 RNA copies/ml), sensitivity was 96.6% (28/29; 95% CI 82.8-99.8) for both self- and professional testing. Deviations in sampling and testing were observed in 25 out of the 40 PCR-positives. Most participants (80.9%) considered the Ag-RDT as easy to perform. CONCLUSION: Laypersons suspected for SARS-CoV-2 infection were able to reliably perform the Ag-RDT and test themselves. Procedural errors might be reduced by refinement of the instructions for use or the product design/procedures. Self-testing allows more wide-spread and frequent testing. Paired with the appropriate information of the public about the benefits and risks, self-testing may have significant impact on the pandemic.