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雅培 Panbio 试剂在有症状的 COVID-19 个体的鼻咽、咽喉和唾液拭子中的临床性能。

Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19.

机构信息

Alberta Public Health Laboratory, Alberta Precision Laboratories, Alberta, Canada.

Department of Pathology and Laboratory Medicine, University of Alberta, Edmonton, Alberta, Canada.

出版信息

Eur J Clin Microbiol Infect Dis. 2021 Aug;40(8):1721-1726. doi: 10.1007/s10096-021-04202-9. Epub 2021 Mar 20.

Abstract

SARS-CoV-2 antigen tests used at the point-of-care, such as the Abbott Panbio, have great potential to help combat the COVID-19 pandemic. The Panbio is Health Canada approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of COVID-19 symptom onset(s). Symptomatic adults recently diagnosed with COVID-19 in the community were recruited into the study. Paired nasopharyngeal (NP), throat, and saliva swabs were collected, with one paired swab tested immediately with the Panbio, and the other transported in universal transport media and tested using real-time reverse-transcriptase polymerase chain reaction (RT-PCR). We also prospectively evaluated results from assessment centers within the community. For those individuals, an NP swab was collected for Panbio testing and paired with RT-PCR results from parallel NP or throat swabs. One hundred and forty-five individuals were included in the study. Collection of throat and saliva was stopped early due to poorer performance (throat sensitivity 57.7%, n=61, and saliva sensitivity 2.6%, n=41). NP swab sensitivity was 87.7% [n=145, 95% confidence interval (CI) 81.0-92.7%]. There were 1641 symptomatic individuals tested by Panbio in assessment centers with 268/1641 (16.3%) positive for SARS-CoV-2. There were 37 false negatives and 2 false positives, corresponding to a sensitivity and specificity of 86.1% [95% CI 81.3-90.0%] and 99.9% [95% CI 99.5-100.0%], respectively. The Panbio test reliably detects most cases of SARS-CoV-2 from adults in the community setting presenting within 7 days of symptom onset using nasopharyngeal swabs. Throat and saliva swabs are not reliable specimens for the Panbio.

摘要

SARS-CoV-2 抗原检测在床边即时检测中具有很大的潜力,可以帮助应对 COVID-19 大流行。雅培 Panbio 抗原检测试剂盒已获得加拿大卫生部批准,用于检测 COVID-19 症状发作 7 天内的有症状个体中的 SARS-CoV-2。本研究招募了最近在社区中被诊断为 COVID-19 的有症状成年人。采集鼻咽(NP)、咽拭子和唾液拭子,其中一份配对拭子立即用 Panbio 进行检测,另一份用通用转运培养基运输并使用实时逆转录聚合酶链反应(RT-PCR)进行检测。我们还前瞻性地评估了社区内评估中心的结果。对于这些个体,采集 NP 拭子进行 Panbio 检测,并与平行 NP 或咽拭子的 RT-PCR 结果配对。本研究共纳入 145 名个体。由于性能较差(咽拭子敏感性 57.7%,n=61,唾液敏感性 2.6%,n=41),停止采集咽拭子和唾液。NP 拭子敏感性为 87.7%[n=145,95%置信区间(CI)81.0-92.7%]。在评估中心,共有 1641 名有症状个体接受 Panbio 检测,其中 268/1641(16.3%)对 SARS-CoV-2 呈阳性。有 37 例假阴性和 2 例假阳性,对应的敏感性和特异性分别为 86.1%[95% CI 81.3-90.0%]和 99.9%[95% CI 99.5-100.0%]。Panbio 检测试剂盒使用鼻咽拭子可靠地检测到社区中出现症状 7 天内的大多数成年人的 SARS-CoV-2 病例。咽拭子和唾液拭子不是 Panbio 的可靠标本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f9b/7979467/8eea106e8924/10096_2021_4202_Fig1_HTML.jpg

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