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用于检测严重急性呼吸综合征冠状病毒 2 的鼻咽拭子、唾液和口腔自我采样拭子的性能、可行性和可接受性。

Performances, feasibility and acceptability of nasopharyngeal swab, saliva and oral-self sampling swab for the detection of severe acute respiratory syndrome coronavirus 2.

机构信息

Microbiology unit, Hôpital d'Instruction des Armées Sainte Anne, Toulon, France.

Microbiology unit, Hôpital d'Instruction des Armées Bégin, Saint-Mandé, France.

出版信息

Eur J Clin Microbiol Infect Dis. 2021 Oct;40(10):2191-2198. doi: 10.1007/s10096-021-04269-4. Epub 2021 May 14.

Abstract

Molecular diagnosis on nasopharyngeal swabs (NPS) is the current standard for COVID-19 diagnosis, but saliva may be an alternative specimen to facilitate access to diagnosis. We compared analytic performances, feasibility and acceptability of NPS, saliva, and oral-self sampling swab for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A prospective, multicenter study was conducted in military hospitals in France among adult outpatients attending COVID-19 diagnosis centers or hospitalized patients. For each patient, all samples were obtained and analyzed simultaneously with RT-PCR or transcription-mediated amplification method. Clinical signs, feasibility, and acceptability for each type of sample were collected. A total of 1220 patients were included, corresponding to 1205 NPS and saliva and 771 OS. Compared to NPS, the sensitivity, specificity, and kappa coefficient for tests performed on saliva were 87.8% (95% CI 83.3-92.3), 97.1% (95% CI 96.1-98.1), and 0.84 (95% CI 0.80-0.88). Analytical performances were better in symptomatic patients. Ct values were significantly lower in NPS than saliva. For OS, sensitivity was estimated to be 61.1% (95% CI 52.7-69.4) and Kappa coefficient to be 0.69 (95% CI 0.62-0.76). OS was the technique preferred by the patients (44.3%) before saliva (42.4%) and NPS (13.4%). Instructions were perceived as simple by patients (> 90%) for saliva and OS. Finally, the painful nature was estimated to be 0.9 for OS, on a scale from 0 to 10, and to be 5.3 for NPS. Performances of OS are not sufficient. Saliva is an acceptable alternative to NPS for symptomatic patient but the process required additional steps to fluidize the sample.

摘要

鼻咽拭子(NPS)的分子诊断是目前 COVID-19 诊断的标准,但唾液可能是一种替代标本,便于进行诊断。我们比较了 NPS、唾液和口腔自我采样拭子在检测严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)中的分析性能、可行性和可接受性。一项前瞻性、多中心研究在法国的军事医院进行,纳入了前往 COVID-19 诊断中心的成年门诊患者或住院患者。对于每个患者,同时使用 RT-PCR 或转录介导扩增方法获得并分析所有样本。收集了每种样本的临床特征、可行性和可接受性。共纳入 1220 例患者,对应 1205 例 NPS 和唾液样本以及 771 例 OS 样本。与 NPS 相比,唾液检测的敏感性、特异性和 Kappa 系数分别为 87.8%(95%CI 83.3-92.3)、97.1%(95%CI 96.1-98.1)和 0.84(95%CI 0.80-0.88)。在有症状的患者中,检测性能更好。NPS 的 Ct 值明显低于唾液。对于 OS,敏感性估计为 61.1%(95%CI 52.7-69.4),Kappa 系数为 0.69(95%CI 0.62-0.76)。OS 是患者首选的技术(44.3%),其次是唾液(42.4%)和 NPS(13.4%)。>90%的患者认为唾液和 OS 的说明简单易懂。最后,估计 OS 的疼痛程度为 0 到 10 之间的 0.9,而 NPS 为 5.3。OS 的性能不足。对于有症状的患者,唾液是 NPS 的可接受替代物,但该过程需要额外的步骤来使样本液化。

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