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用于 SARS-CoV-2 抗原检测的前鼻采集的诊断性能和特征:一项前瞻性研究。

Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: a prospective study.

机构信息

Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 3058576, Japan.

Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 3058558, Japan.

出版信息

Sci Rep. 2021 May 18;11(1):10519. doi: 10.1038/s41598-021-90026-8.

DOI:10.1038/s41598-021-90026-8
PMID:34006975
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8131686/
Abstract

The clinical utility of antigen test using anterior nasal samples has not been well evaluated. We conducted a prospective study in a drive-through testing site located at a PCR center to evaluate the diagnostic performance of the antigen test QuickNavi-COVID19 Ag using anterior nasal samples and to compare the degrees of coughs or sneezes induction and the severity of pain between anterior nasal collection and nasopharyngeal collection. The study included a total of 862 participants, of which 91.6% were symptomatic. The median duration from symptom onset to sample collection was 2.0 days. Fifty-one participants tested positive for severe acute respiratory syndrome coronavirus 2 on reverse transcription PCR (RT-PCR) with nasopharyngeal samples, and all of them were symptomatic. In comparison to the findings of RT-PCR, the antigen test using anterior nasal samples showed 72.5% sensitivity (95% confidence interval [CI] 58.3-84.1%) and 100% specificity (95% CI 99.3-100%). Anterior nasal collection was associated with a significantly lower degree of coughs or sneezes induction and the severity of pain in comparison to nasopharyngeal collection (p < 0.001). The antigen test using anterior nasal samples showed moderate sensitivity in symptomatic patients who were at the early stages of the disease course but was less painful and induced fewer coughs or sneezes.

摘要

使用前鼻样本的抗原检测的临床实用性尚未得到很好的评估。我们在位于聚合酶链反应(PCR)中心的一个免下车检测点进行了一项前瞻性研究,以评估使用前鼻样本的抗原检测 QuickNavi-COVID19 Ag 的诊断性能,并比较前鼻采集和鼻咽采集引起的咳嗽或打喷嚏程度以及疼痛的严重程度。该研究共纳入了 862 名参与者,其中 91.6%有症状。从症状出现到样本采集的中位时间为 2.0 天。51 名参与者的鼻咽样本 RT-PCR 检测结果为严重急性呼吸综合征冠状病毒 2 阳性,且均有症状。与 RT-PCR 结果相比,前鼻样本的抗原检测显示出 72.5%的敏感性(95%置信区间 [CI] 58.3-84.1%)和 100%的特异性(95% CI 99.3-100%)。与鼻咽采集相比,前鼻采集引起的咳嗽或打喷嚏程度以及疼痛的严重程度明显较低(p<0.001)。在前鼻样本的抗原检测中,在疾病早期的有症状患者中显示出中等敏感性,但疼痛较轻,引起的咳嗽或打喷嚏较少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/47ae0d3ce8a1/41598_2021_90026_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/0134a546ff73/41598_2021_90026_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/e0a8490f58da/41598_2021_90026_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/47ae0d3ce8a1/41598_2021_90026_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/0134a546ff73/41598_2021_90026_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/e0a8490f58da/41598_2021_90026_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8687/8131686/47ae0d3ce8a1/41598_2021_90026_Fig3_HTML.jpg

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The evaluation of a newly developed antigen test (QuickNavi™-COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan.一种新型抗原检测试剂(QuickNavi™-COVID19 Ag)用于 SARS-CoV-2 的评估:日本的一项前瞻性观察研究。
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