Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test.
Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test.
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DOI：
10.1016/j.jcv.2021.104874
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Mockenhaupt FP
中科院分区：
文献类型：
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作者：
Lindner AK;Nikolai O;Rohardt C;Kausch F;Wintel M;Gertler M;Burock S;Hörig M;Bernhard J;Tobian F;Gaeddert M;Lainati F;Corman VM;Jones TC;Sacks JA;Seybold J;Denkinger CM;Mockenhaupt FP
考虑到鼻腔自我采样的可能性和在进行SARS-CoV-2抗原检测快速诊断测试（Ag-RDTs）中的易用性，自我检测是一个可行的选择。这项研究的目的是对患者自我检测与使用SARS-CoV-2 Ag-RDT的专业检测的诊断准确性进行头对头比较。我们使用WHO列出的SARS-CoV-2 Ag-RDT对有症状的成人进行了一项鼻中鼻甲自我采样和自我检测的独立于患者的前瞻性诊断准确性研究。观察手术，未进行干预。为了进行比较，专业地进行了鼻咽取样的Ag-RDT。估计协议，灵敏度和特异性相对于RT-PCR的合并口腔/鼻咽样本进行计算。通过观察员和参与者问卷调查评估可行性。在146例有症状的成人中，40例（27.4%）为SARS-CoV-2的RT-PCR阳性。自我检测的灵敏度为82.5%（33/40; 95% CI 68.1-91.3），专业检测的灵敏度为85.0%（34/40; 95% CI 70.9-92.9）。在高病毒载量（≥7.0 log 10 SARS-CoV-2 RNA拷贝/ml）下，自我和专业检测的灵敏度均为96.6%（28/29; 95% CI 82.8-99.8）。在40例PCR阳性中的25例中观察到采样和检测偏差。大多数参与者（80.9%）认为Ag-RDT易于执行。被怀疑感染SARS-CoV-2的非专业人员能够可靠地进行Ag-RDT并进行自我检测。通过细化使用说明书或产品设计/程序可减少程序错误。自测试允许更广泛和更频繁的测试。结合公众关于益处和风险的适当信息，自我检测可能对大流行产生重大影响。
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.
影响因子：
13.8
作者：
Paltiel, A. David;Zheng, Amy;Walensky, Rochelle P.
通讯作者：
Walensky, Rochelle P.