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.
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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DOI：
10.1016/j.ijid.2021.02.098
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发表时间：
2021-04
期刊：
影响因子：
--
通讯作者：
Mencacci A
中科院分区：
文献类型：
--
作者：
Gili A;Paggi R;Russo C;Cenci E;Pietrella D;Graziani A;Stracci F;Mencacci A
目的比较Lumipulse®SARS-CoV-2抗原检测方法与金标准实时逆转录-聚合酶链式反应(RT-PCR)在SARS-CoV-2感染诊断中的作用。对226例疑似SARS-CoV-2感染者进行Lumipulse®SARS-CoV-2抗原检测与金标准RT-PCR检测的比较，并对其准确性进行评价。随后，这项测试被应用于1738例患者的真实筛查队列。ROC分析用于探索测试特征和临界值。所有测试都是在意大利翁布里亚的区域参考实验室进行的。在选定的队列中，RT-PCR的阳性结果为42.0%。Lumipulse®系统在1.24pg/mL的最佳界值时，敏感性为92.6%(95%CI 85.4~97.0%)，特异性为90.8%(95%CI 84.5~95.2%)。在以5.2%感染率为特征的筛查队列中，Lumipulse®法在1.645 pg/mL的最佳界值时显示出100%的敏感性(95%CI 96.0-100.0%)和94.8%的特异性(95%CI 93.6-95.8%)；AUC为97.4%，NPV为100%(95%CI 99.8-100.0%)，PPV为51.1%(95%CI 43.5-58.7%)。Lumipulse®SARS-CoV-2抗原检测可安全地用于小型和大型社区以及普通人群的筛查策略。
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.
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