Diagnostic accuracy of SARS-CoV-2 saliva antigen testing in a real-life clinical setting.

Diagnostic accuracy of SARS-CoV-2 saliva antigen testing in a real-life clinical setting.
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DOI:
10.1016/j.ijid.2022.03.037
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发表时间:
2022-06
期刊:
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
影响因子:
--
通讯作者:
Nagler M
Nagler M
中科院分区:
其他
文献类型:
--
作者:
Jegerlehner S;Suter-Riniker F;Jent P;Bittel P;Nagler M

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唾液SARS-CoV-2抗原检测有助于在缺乏训练有素人员的情况下进行检查。然而,很少有人知道在现实生活中的临床设置的诊断准确性。因此,我们研究了唾液抗原检测在诊断SARS-CoV-2感染的诊断准确性在初级/二级保健检测设施。前瞻性招募了在瑞士大学医院附属COVID-19检测机构就诊的个人(n=377)。获得唾液样本,并且PCL Inc. COVID 19 Gold抗原检测与鼻咽拭子的2种实时聚合酶链反应(RT-PCR)检测平行进行。RT-PCR结果为阳性的53个人,对应的患病率为14.1%(1个人的材料丢失)。PCL唾液抗原检测阳性22例(5.8%),阴性354例(93.9%)。总体和有症状的个体中,唾液抗原检测的灵敏度为30.2%(95%置信区间18.3,44.3)。特异性为98.1%(96.0,99.3)。SARS-CoV-2唾液抗原检测在初级/二级保健检测设施的诊断准确性明显低于制造商的规格报告。
SARS-CoV-2 antigen tests with saliva facilitate examination in settings that lack trained personnel. However, little is known about the diagnostic accuracy in real-life clinical settings. Therefore, we studied the diagnostic accuracy of a saliva antigen test in diagnosing SARS-CoV-2 infection in a primary/secondary care testing facility. Individuals who presented at a COVID-19 testing facility affiliated with a Swiss university hospital were prospectively recruited (n=377). Saliva specimen was obtained, and the PCL Inc. COVID19 Gold antigen test was conducted in parallel with 2 real-time polymerase chain reaction (RT-PCR) assays from a nasopharyngeal swab. RT-PCR results were positive in 53 individuals, corresponding to a prevalence of 14.1% (missing material in 1 individual). The PCL saliva antigen test was positive in 22 individuals (5.8%) and negative in 354 (93.9%). The sensitivity of the saliva antigen test was 30.2% (95% confidence interval 18.3, 44.3), both overall and in symptomatic individuals. The specificity was 98.1% (96.0, 99.3). The diagnostic accuracy of a SARS-CoV-2 saliva antigen test in a primary/secondary care testing facility was remarkably lower than that reported in the manufacturer's specifications.
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影响因子: --
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