Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children.
Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children.
复制标题
Lumiradx微流体免疫荧光的性能在无症状的成年人和儿童中的现状SARS-COV-2抗原测试。
DOI：
10.1093/ajcp/aqab173
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发表时间：
2022-04-01
影响因子：
3.5
通讯作者：
Ellis JE
中科院分区：
文献类型：
--
作者：
Drain P;Sulaiman R;Hoppers M;Lindner NM;Lawson V;Ellis JE
LumiraDx SARS-CoV-2 Ag Test此前已被证明可准确检测2019冠状病毒病（COVID-19）症状个体的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）。本评价研究了LumiraDx SARS-CoV-2 Ag Test作为辅助诊断无症状成人和儿童SARS-CoV-2感染的方法。在5个护理点（POC）环境中招募了处于COVID-19感染高风险的无症状个体。从每名受试者中采集两对前鼻拭子，在POC使用LumiraDx SARS-CoV-2 Ag Test进行检测，并与逆转录聚合酶链反应（RT-PCR）检测（cobas 6800 [Roche Diagnostics]或TaqPath [Thermo Fisher Scientific]）的结果进行比较。我们计算阳性一致率（PPA）和阴性一致率（NPA），然后根据RT-PCR参考平台和循环阈值对结果进行分层。在纳入的222名研究参与者中，确认在测试前至少2周内没有发生过乳腺癌，PPA为82.1%（95%置信区间[CI]，64.4%-92.1%）。LumiraDx SARS-CoV-2 Ag Test在少于33个RT-PCR循环中正确识别了95.8%（95% CI，79.8%-99.3%）的确认阳性样本，在少于30个RT-PCR循环中正确识别了100%（95% CI，85.1%-100%）的确认阳性样本，同时保持100% NPA。这种快速、高灵敏度的检测可用于在诊所和社区环境中筛查急性SARS-CoV-2感染的无症状患者。
The LumiraDx SARS-CoV-2 Ag Test has previously been shown to accurately detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals symptomatic for coronavirus disease 2019 (COVID-19). This evaluation investigated the LumiraDx SARS-CoV-2 Ag Test as an aid in the diagnosis of SARS-CoV-2 infection in asymptomatic adults and children. Asymptomatic individuals at high risk of COVID-19 infection were recruited in 5 point-of-care (POC) settings. Two paired anterior nasal swabs were collected from each participant, tested by using the LumiraDx SARS-CoV-2 Ag Test at the POC, and compared with results from reverse transcription–polymerase chain reaction (RT-PCR) assays (cobas 6800 [Roche Diagnostics] or TaqPath [Thermo Fisher Scientific]). We calculated positive percent agreement (PPA) and negative percent agreement (NPA), then stratified results on the basis of RT-PCR reference platform and cycle threshold. Of the 222 included study participants confirmed to be symptom-free for at least 2 weeks before testing, the PPA was 82.1% (95% confidence interval [CI], 64.4%-92.1%). The LumiraDx SARS-CoV-2 Ag Test correctly identified 95.8% (95% CI, 79.8%-99.3%) of the samples confirmed positive in fewer than 33 RT-PCR cycles and 100% (95% CI, 85.1%-100%) in fewer than 30 RT-PCR cycles while maintaining 100% NPA. This rapid, high-sensitivity test can be used to screen asymptomatic patients for acute SARS-CoV-2 infection in clinic- and community-based settings.
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DOI：
10.15585/mmwr.mm695152a3
发表时间：
2021-01-01
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
通讯作者：
--
影响因子：
28.3
作者：
Gorbalenya, Alexander E.;Baker, Susan C.;Ziebuhr, John
通讯作者：
Ziebuhr, John
影响因子：
5.4
作者：
Drain PK;Ampajwala M;Chappel C;Gvozden AB;Hoppers M;Wang M;Rosen R;Young S;Zissman E;Montano M
通讯作者：
Montano M
DOI：
10.1007/s10096-020-03913-9
发表时间：
2020-04-27
影响因子：
4.5
作者：
La Scola, Bernard;Le Bideau, Marion;Raoult, Didier
通讯作者：
Raoult, Didier
影响因子：
15.1
作者：
Peto T;UK COVID-19 Lateral Flow Oversight Team
通讯作者：
UK COVID-19 Lateral Flow Oversight Team