Gili Alessio, Paggi Riccardo, Russo Carla, Cenci Elio, Pietrella Donatella, Graziani Alessandro, Stracci Fabrizio, Mencacci Antonella
Public Health Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
Microbiology and Clinical Microbiology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
Int J Infect Dis. 2021 Apr;105:391-396. doi: 10.1016/j.ijid.2021.02.098. Epub 2021 Feb 26.
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.
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.
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%).
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.
比较Lumipulse® SARS-CoV-2抗原检测与诊断SARS-CoV-2感染的金标准实时逆转录-聚合酶链反应（RT-PCR），并评估其在筛查项目中的作用。
在226例疑似SARS-CoV-2感染的选定队列中，将Lumipulse® SARS-CoV-2抗原检测与金标准RT-PCR检测进行比较，并评估其准确性。随后，对1738例病例的实际筛查队列进行该检测。进行ROC分析以探索检测特征和临界值。所有检测均在意大利翁布里亚的地区参考实验室进行。
在选定队列中观察到RT-PCR阳性结果为42.0%。Lumipulse®系统在最佳临界值为1.24 pg/mL时，敏感性为92.6%（95%CI 85.4-97.0%），特异性为90.8%（95%CI 84.5-95.2%）。在感染率为5.2%的筛查队列中，Lumipulse®检测在最佳临界值为1.645 pg/mL时，敏感性为100%（95%CI 96.0-100.0%），特异性为94.8%（95%CI 93.6-95.8%）；曲线下面积为97.4%，阴性预测值为100%（95%CI 99.8-100.0%），阳性预测值为51.1%（95%CI 43.5-58.7%）。
Lumipulse® SARS-CoV-2抗原检测可安全用于大小社区及普通人群的筛查策略。
