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10.1016/j.jcv.2021.104874

http://scihub22266oqcxt.onion/10.1016/j.jcv.2021.104874
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34144452!8163726!34144452
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suck abstract from ncbi


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pmid34144452      J+Clin+Virol 2021 ; 141 (ä): 104874
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  • Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test #MMPMID34144452
  • Lindner AK; Nikolai O; Rohardt C; Kausch F; Wintel M; Gertler M; Burock S; Horig M; Bernhard J; Tobian F; Gaeddert M; Lainati F; Corman VM; Jones TC; Sacks JA; Seybold J; Denkinger CM; Mockenhaupt FP
  • J Clin Virol 2021[Aug]; 141 (ä): 104874 PMID34144452show ga
  • 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.
  • |*COVID-19[MESH]
  • |*SARS-CoV-2[MESH]
  • |Adult[MESH]
  • |Antigens, Viral[MESH]
  • |Feasibility Studies[MESH]
  • |Humans[MESH]
  • |Prospective Studies[MESH]
  • |RNA, Viral[MESH]
  • |Self-Testing[MESH]


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