Abstract
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 log 10 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.
Keywords: Antigen-detecting rapid diagnostic test; COVID-19; SARS-CoV-2; Self-swab; Self-testing.
【저자키워드】 COVID-19, SARS-CoV-2, Self-swab, Antigen-detecting rapid diagnostic test, self-testing, 【초록키워드】 pandemic, SARS-COV-2 infection, diagnostic test, diagnostic, Intervention, nasal, RT-PCR, Antigen, sensitivity, specificity, Diagnostic accuracy, Accuracy, Self-swab, Rapid diagnostic test, Viral load, RNA copies, nasopharyngeal, Patient, sampling, SARS-CoV-2 RNA, SARS-CoV-2 antigen, Head-to-head comparison, estimate, information, Ag-RDT, Questionnaires, 95% CI, head, high viral load, Ag-RDTs, participant, symptomatic adults, refinement, layperson, MOST, nasopharyngeal sampling, procedure, benefit, log, performed, evaluated, reduced, calculated, feasible, symptomatic adult, 【제목키워드】 feasibility, Rapid test, Patient,