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首页> 外文期刊>International journal of infectious diseases : >Evaluation of Lumipulse? G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening
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Evaluation of Lumipulse? G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening

机译：对清藏客的评价？ G SARS-COV-2抗原测定用于检测鼻咽拭子的SARS-COV-2核衣壳蛋白（NP）的抗原测定用于群落和人口筛查的SARS-COV-2核衣壳蛋白（NP）

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Objectives To compare the Lumipulse? SARS-CoV-2 antigen test with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) for diagnosis of SARS-CoV-2 infection and to evaluate its role in screening programs. Methods Lumipulse? SARS-CoV-2 antigen assay was compared with the gold standard RT-PCR test in a selected cohort of 226 subjects with suspected SARS-CoV-2 infection, and its accuracy was evaluated. Subsequently, the test was administered to a real-life screening cohort of 1738 cases. ROC analysis was performed to explore test features and cutoffs. All tests were performed in the regional reference laboratory in Umbria, Italy. Results A 42.0% positive result at RT-PCR was observed in the selected cohort. The Lumipulse? system showed 92.6% sensitivity (95% CI 85.4–97.0%) and 90.8% specificity (95% CI 84.5–95.2%) at 1.24 pg/mL optimal cutoff. In the screening cohort, characterized by 5.2% prevalence of infection, Lumipulse? assay showed 100% sensitivity (95% CI 96.0–100.0%) and 94.8% specificity (95% CI 93.6–95.8%) at 1.645 pg/mL optimal cutoff; the AUC was 97.4%, NPV was 100% (95% CI 99.8–100.0%) and PPV was 51.1% (95% CI 43.5–58.7%). Conclusions The Lumipulse? SARS-CoV-2 antigen assay can be safely employed in the screening strategies in small and large communities and in the general population.
机译：目标可以比较少灯吗？ SARS-COV-2抗原试验与金标准实时逆转录 - 聚合酶链反应（RT-PCR）用于诊断SARS-COV-2感染，并评估其在筛查方案中的作用。方法lumipulse？将SARS-COV-2抗原测定与疑似SARS-COV-2感染的226个受试者的226个受试者中的金标准RT-PCR试验进行比较，评价其精度。随后，将试验施用于1738例的真实筛查队列。进行ROC分析以探索测试功能和截止值。所有测试均在意大利翁布里亚的区域参考实验室进行。结果在选定的队列中观察到42.0％的RT-PCR阳性结果。少灯？系统显示出92.6％的灵敏度（95％CI 85.4-97.0％）和90.8％的特异性（95％CI 84.5-95.2％），在1.24 pg / ml最佳截止。在筛查队列中，其特征在于感染5.2％的感染率，清晰？测定显示敏感度100％（95％CI 96.0-100.0％）和94.8％的特异性（95％CI 93.6-95.8％），在1.645 pg / ml最佳截止值; AUC为97.4％，NPV为100％（95％CI 99.8-100.0％）和PPV为51.1％（95％CI 43.5-58.7％）。结论少灯？ SARS-COV-2抗原测定可以安全地在小型社区和一般人群中进行筛选策略。

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