<br>在护理点进行的鼻咽 Panbio COVID-19 抗原对传播风险较高和年龄较大的有症状和无症状患者具有高敏感性,Open Forum Infectious Diseases

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在护理点进行的鼻咽 Panbio COVID-19 抗原对传播风险较高和年龄较大的有症状和无症状患者具有高敏感性
Open Forum Infectious Diseases ( IF 3.8 ) Pub Date : 2021-02-05 , DOI: 10.1093/ofid/ofab059
Mar Masiá _{1,

2} , Marta Fernández-González ₁ , Manuel Sánchez ₃ , Mar Carvajal ₁ , José Alberto García ₁ , Nieves Gonzalo-Jiménez ₄ , Victoria Ortiz de la Tabla ₅ , Vanesa Agulló ₁ , Inmaculada Candela ₆ , Jorge Guijarro ₇ , José Antonio Gutiérrez ₈ , Carlos de Gregorio ₃ , Félix Gutiérrez _{1,

2}

Affiliation

背景床旁检测在不同临床场景和不同样本上的性能仍不确定。我们全面评估了Panbio鼻咽部COVID-19 Ag快速检测装置的性能。方法这是一项前瞻性研究，纳入了就诊于 3 个初级保健中心 (PCC) 和一个急诊科的连续患者。在护理点对鼻咽拭子和唾液进行抗原检测。以逆转录聚合酶链反应（RT-PCR）测定作为参考标准计算阳性一致性百分比（PPA）和阴性一致性百分比（NPA）。结果 913 例患者中，296 例（32.3%）无症状，690 例（75.6%）来自 PCC。收集了913名患者的鼻咽拭子，收集了659名患者的鼻拭子，收集了611名患者的唾液。 196 份 (21.5%) 鼻咽样本 (NPS) 的 RT-PCR 呈阳性。总体而言，NPS 中的 PPA (95% CI) 为 60.5% (53.3–67.4)，鼻拭子 (44.7%) 和唾液 (23.1%) 中的 PPA 较低。 NPS 中的测试性能很大程度上取决于 RT-PCR 中的循环阈值 (Ct)，对于 Ct ≤ 25，PPA 为 94%，对于 Ct <30，PPA 为 80%。在有症状的患者中，Ct ≤ 25 的 PPA 为 95%，Ct <30 的 PPA 为 85%，发烧、咳嗽和不适三联征的 PPA 为 89%。表现还取决于年龄，>50 岁、Ct <25 的有症状患者的 PPA 为 100%。在无症状患者中，Ct <25 的 PPA 为 86%。在所有情况下，NPA 均为 100%。结论在床旁进行的鼻咽 Panbio COVID-19 Ag 检测对于 Ct <30 及年龄较大的有症状患者具有良好的敏感性。该测试有助于识别 Ct 值较低的无症状患者。

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Nasopharyngeal Panbio COVID-19 Antigen Performed at Point-of-Care Has a High Sensitivity in Symptomatic and Asymptomatic Patients With Higher Risk for Transmission and Older Age

Background Performance of point-of-care tests in different clinical scenarios and on different samples remains undetermined. We comprehensively evaluated the performance of the nasopharyngeal Panbio COVID-19 Ag Rapid Test Device. Methods This is a prospective study that includes consecutive patients attending 3 primary care centers (PCCs) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs and in saliva. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated with the reverse-transcription polymerase chain reaction (RT-PCR) assay as reference standard. Results Of 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913 patients, nasal swabs were collected from 659 patients, and saliva was collected from 611 patients. The RT-PCR was positive in 196 (21.5%) nasopharyngeal samples (NPS). Overall, PPA (95% CI) in NPS was 60.5% (53.3–67.4), and it was lower in nasal swabs (44.7%) and saliva (23.1%). Test performance in NPS was largely dependent on the cycle threshold (Ct) in RT-PCR, with PPA of 94% for Ct ≤25 and 80% for Ct <30. In symptomatic patients, the PPA was 95% for Ct ≤25, 85% for Ct <30, and 89% for the symptom triad of fever, cough, and malaise. Performance was also dependent on age, with a PPA of 100% in symptomatic patients >50 years with Ct <25. In asymptomatic patients, the PPA was 86% for Ct <25. In all cases, NPA was 100%. Conclusions The nasopharyngeal Panbio COVID-19 Ag test performed at point-of-care has a good sensitivity in symptomatic patients with Ct <30 and older age. The test was useful to identify asymptomatic patients with lower Ct values.

更新日期：2021-02-05

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