A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study.
A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study.
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DOI：
10.1007/s40121-021-00413-x
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发表时间：
2021-06
影响因子：
5.4
通讯作者：
Montano M
中科院分区：
文献类型：
--
作者：
Drain PK;Ampajwala M;Chappel C;Gvozden AB;Hoppers M;Wang M;Rosen R;Young S;Zissman E;Montano M
LumiraDx严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）抗原检测使用高灵敏度微流控免疫测定法检测SARS-CoV-2的核衣壳蛋白，在床旁环境中对成人和儿童2019年急性冠状病毒病（COVID-19）的诊断进行了评价（NCT 04557046）。从每名参与者中采集两对前鼻拭子或两对鼻咽拭子。通过LumiraDx SARS-CoV-2抗原检测对拭子进行检测，并与实时聚合酶链反应（rt-PCR; Roche cobas 6800平台）进行比较。计算敏感性、特异性和似然比。根据性别、年龄、症状持续时间和rt-PCR循环阈值对结果进行分层。在这项前瞻性验证研究的512名0-90岁参与者中，414名（81%）有COVID-19症状，123名（24%）拭子基于rt-PCR检测呈SARS-CoV-2阳性。与rt-PCR相比，在发病12 d内（代表感染期），12 min鼻拭子试验的敏感性为97.6%，特异性为96.6%，鼻咽拭子试验的敏感性为97.5%，特异性为97.7%。在33个rt-PCR循环内检出的所有（100%）样本也使用抗原检测进行了鉴别。结果在不同年龄和性别之间是一致的。当由最低限度培训的操作员使用时，测试系统的用户错误率为0.7%（95%置信区间[CI] 0.1-3.7%）。使用鼻咽或前鼻采样的快速，高灵敏度检测可能为临床和社区环境中诊断急性SARS-CoV-2感染提供显着改进。在线版本包含补充材料，可通过10.1007/s40121-021-00413-x获得。
The LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point-of-care settings (NCT04557046). Two paired anterior nasal swabs or two paired nasopharyngeal swabs were collected from each participant. Swabs were tested by the LumiraDx SARS-CoV-2 antigen test and compared with real-time polymerase chain reaction (rt-PCR; Roche cobas 6800 platform). Sensitivity, specificity and likelihood ratios were calculated. Results were stratified on the basis of gender, age, duration of symptoms, and rt-PCR cycle threshold. Out of the 512 participants, aged 0–90 years, of this prospective validation study, 414 (81%) were symptomatic for COVID-19 and 123 (24%) swabs were positive for SARS-CoV-2 based on rt-PCR testing. Compared with rt-PCR, the 12-min nasal swab test had 97.6% sensitivity and 96.6% specificity, and nasopharyngeal swab had 97.5% sensitivity and 97.7% specificity, within 12 days of symptom onset, representing the period of infectivity. All (100%) samples detected within 33 rt-PCR cycles were also identified using the antigen test. Results were consistent across age and gender. The user error rate of the test system when used by minimally trained operators was 0.7% (95% confidence interval [CI] 0.1–3.7%). The rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling may offer significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings. The online version contains supplementary material available at 10.1007/s40121-021-00413-x.
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影响因子：
19
作者：
Singanayagam, Anika;Patel, Monika;Gopal, Robin
通讯作者：
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影响因子：
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Poliquin, Guillaume
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：
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影响因子：
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