Evaluation of an antigen-based test for hospital point-of-care diagnosis of SARS-CoV-2 infection.
Evaluation of an antigen-based test for hospital point-of-care diagnosis of SARS-CoV-2 infection.
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DOI：
10.1016/j.jcv.2021.104838
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发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Costa C
中科院分区：
文献类型：
--
作者：
Bianco G;Boattini M;Barbui AM;Scozzari G;Riccardini F;Coggiola M;Lupia E;Cavallo R;Costa C
准确的诊断对于识别和管理SARS-CoV-2感染患者并实施感染控制措施至关重要。尽管实时逆转录聚合酶链反应（RT-PCR）是目前推荐的实验室方法，但已开发了几种快速抗原床旁检测（POCT）作为SARS-CoV-2感染诊断的一线检测。本研究的目的是评估最近CE批准的POCT，在LumiraDx™平台（LumiraDx GmbH，科隆，德国）上进行的SARS-CoV-2 Ag检测，用于在医院环境中识别SARS-COV-2感染受试者。LumiraDx POCT在意大利SARS-CoV-2大流行第二个高峰期的沿着两个月期间在三个医院环境中实施：成人和儿科急诊科以及职业医学科。对直接鼻拭子进行快速抗原检测，并将结果与Xpert Xpress SARS-CoV-2检测试剂盒获得的结果进行比较。与参考方法相比，总体灵敏度、特异性、NPV和PPV分别为90.3%、92.1%、95.1%和84.9%。症状组的敏感性、特异性、PPV和NPV分别为89.3% [95%IC 84.2-93.3]、88.2% [95%IC 72.5-96.7]、97.8% [95%IC 94.6-99.1]和58.8% [95%IC 48.4-68.5]。无症状组的敏感性、特异性、PPV和NPV分别为92.1% [95%IC 85-96.5]、92.3% [95%IC 89.9-94.4]、67.9% [95%IC 61.3-73.8]和98.5% [95%IC 97.1-99.2]。观察有症状组和无症状组的假阳性和假阴性结果。SARS-CoV-2 Ag POCT可能是一种快速识别有症状或无症状感染受试者的有趣工具。然而，在假阴性或假阳性结果可能具有相关影响的医院环境中，对于患者的适当管理，确证性NAAT始终是必要的。
An accurate diagnosis is essential to identify and manage SARS-CoV-2 infected patients and implement infection control measures. Although real-time reverse transcription polymerase chain reaction (RT-PCR) is the current recommended laboratory method, several rapid antigen point-of-care tests (POCTs) were developed as frontline testing for SARS-CoV-2 infection diagnosis. The aim of this study was to assess a recently CE-approved POCT, SARS-CoV-2 Ag Test on the LumiraDx™ Platform (LumiraDx GmbH, Cologne, Germany) for the identification of SARS-COV-2 infected subjects at hospital setting. LumiraDx POCT was implemented in three hospital settings: adult and pediatric emergency departments and occupational medicine department along two-month period during the second peak of Italian SARS-CoV-2 pandemic. Rapid antigen testing was performed on direct nasal swabs and results were compared with those obtained by Xpert Xpress SARS-CoV-2 assay. Overall sensitivity, specificity, NPV and PPV were 90.3%, 92.1%, 95.1%, and 84.9%, respectively, compared to reference method. Sensitivity, specificity, PPV and NPV for symptomatic group were 89.3% [95% IC 84.2-93.3], 88.2% [95% IC 72.5-96.7], 97.8% [95% IC 94.6-99.1], and 58.8% [95% IC 48.4-68.5], respectively. Sensitivity, specificity, PPV and NPV for asymptomatic group were 92.1% [95% IC 85-96.5], 92.3% [95% IC 89.9-94.4], 67.9% [95% IC 61.3-73.8], and 98.5% [95% IC 97.1-99.2], respectively. False positive and negative antigen testing results in both symptomatic and asymptomatic group were observed. SARS-CoV-2 Ag POCT may represent an interesting tool to rapidly identify symptomatic or asymptomatic infected subjects. However, in hospital setting in which false negative or false positive results may have relevant implications, confirmatory NAAT always remains necessary for the appropriate management of patients.
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影响因子：
5.4
作者：
Osterman A;Baldauf HM;Eletreby M;Wettengel JM;Afridi SQ;Fuchs T;Holzmann E;Maier A;Döring J;Grzimek-Koschewa N;Muenchhoff M;Protzer U;Kaderali L;Keppler OT
通讯作者：
Keppler OT
影响因子：
8.4
作者：
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Omata, Masao
影响因子：
3.9
作者：
Kohmer N;Toptan T;Pallas C;Karaca O;Pfeiffer A;Westhaus S;Widera M;Berger A;Hoehl S;Kammel M;Ciesek S;Rabenau HF
通讯作者：
Rabenau HF
DOI：
10.1016/j.jcv.2020.104712
发表时间：
2021-01
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
--
作者：
Mak GCK;Lau SSY;Wong KKY;Chow NLS;Lau CS;Lam ETK;Chan RCW;Tsang DNC
通讯作者：
Tsang DNC
DOI：
10.1016/j.jcv.2020.104659
发表时间：
2020-12
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
--
作者：
Linares M;Pérez-Tanoira R;Carrero A;Romanyk J;Pérez-García F;Gómez-Herruz P;Arroyo T;Cuadros J
通讯作者：
Cuadros J