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

• Published in: Journal of clinical virology Vol. 141; p. 104874
• Main Authors: Lindner, Andreas K., Nikolai, Olga, Rohardt, Chiara, Kausch, Franka, Wintel, Mia, Gertler, Maximilian, Burock, Susen, Hörig, Merle, Bernhard, Julian, Tobian, Frank, Gaeddert, Mary, Lainati, Federica, Corman, Victor M., Jones, Terry C., Sacks, Jilian A., Seybold, Joachim, Denkinger, Claudia M., Mockenhaupt, Frank P.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.08.2021
• Subjects: Adult; Antigen-detecting rapid diagnostic test; Antigens, Viral; COVID-19; Feasibility Studies; Humans; Prospective Studies; RNA, Viral; SARS-CoV-2; Self-swab; Self-Testing; Sensitivity and Specificity; Short Communication; COVID-19; Self-testing; Self-swab; SARS-CoV-2; Antigen-detecting rapid diagnostic test
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2021.104874

•Head-to-head comparison of a SARS-CoV-2 rapid antigen test with self- and professional use.•With nasal self-sampling versus professional nasopharyngeal sampling.•Sensitivity with self-testing was 82.5% (33/40), with professional testing 85.0% (34/40).•Positive percent agreement (91.4%) and inter-rater reliability (kappa 0.98) were high.•Most patients (80.9%) considered the rapid antigen test as easy to perform. 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. 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. 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. 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. 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.