Comparison of the Quantitative DiaSorin Liaison Antigen Test to Reverse Transcription-PCR for the Diagnosis of COVID-19 in Symptomatic and Asymptomatic Outpatients
Comparison of the Quantitative DiaSorin Liaison Antigen Test to Reverse Transcription-PCR for the Diagnosis of COVID-19 in Symptomatic and Asymptomatic Outpatients
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DOI：
10.1128/jcm.00374-21
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发表时间：
2021-07-01
影响因子：
9.4
通讯作者：
Vermeersch, Pieter
中科院分区：
文献类型：
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作者：
Lefever, Stefanie;Indevuyst, Christophe;Vermeersch, Pieter
我们评估了在病毒稳定强烈循环期间（213/100,000居民/天）就诊的有症状和无症状个体的冠状病毒2型（SARS-CoV-2）抗原定量检测。从就诊患者的新鲜常规鼻咽样本中随机抽取剩余逆转录pcr阳性（n= 204）和阴性（n= 210）鼻咽样本。根据制造商的说明，样品在Liaison XL上进行了测试。模棱两可的结果被认为是阴性的。与RTPCR相比，联络抗原检测的总体敏感性和特异性分别为65.7%（95%可信区间[CI]， 58.9% ~ 71.9%）和100% （CI, 97.8% ~ 100%）。在病毒载量为>0(5)、>10(4)和>10(3)拷贝/ml的样品中，灵敏度分别为100% （CI, 96.3% ~ 100.0%）、96.5% （CI, 91.8% ~ 98.7%）和87.4% （CI, 81.3% ~ 91.5%）。所有103拷贝/ml的样本均为抗原阴性。在10(5)拷贝/ml的样本中，抗原浓度与病毒载量之比在有症状的参与者中没有显著高于无症状的参与者（63.9% [CI， 54.9%至72.0%]对51.9% [CI， 41.1%至62.6%];P = 0.11），但低病毒载量（= 10(4)拷贝/ml）的参与者比例为96.5%和100%。抗原浓度与病毒载量的相关性在有症状和无症状个体中具有可比性。
We evaluated the quantitative DiaSorin Liaison severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test in symptomatic and asymptomatic individuals consulting their general practitioners (GPs) during a period of stable intense virus circulation (213/100,000 habitants per day). Leftover reverse transcription-PCR (RT-PCR) positive (n= 204) and negative (n= 210) nasopharyngeal samples were randomly selected among fresh routine samples collected from patients consulting their GPs. Samples were tested on Liaison XL according to the manufacturer's instructions. Equivocal results were considered negative. The overall sensitivity and specificity of the Liaison antigen test compared to RTPCR were 65.7% (95% confidence interval [CI], 58.9% to 71.9%) and 100% (CI, 97.8% to 100%). Sensitivity in samples with viral loads of >10(5), >10(4), and >10(3) copies/ml were 100% (CI, 96.3% to 100.0%), 96.5% (CI, 91.8% to 98.7%), and 87.4% (CI, 81.3% to 91.5%), respectively. All samples with #103 copies/ml were antigen negative. The ratio of antigen concentration to viral load in samples with = 10(5) copies/ml) was not significantly higher in symptomatic than in asymptomatic participants (63.9% [CI, 54.9% to 72.0%] versus 51.9% [CI, 41.1% to 62.6%]; P = 0.11), but the proportion of participants with a low viral load (= 10(4) copies/ml were 96.5% and 100%. The correlation of antigen concentration with viral load was comparable in symptomatic and asymptomatic individuals.