Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups
Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups
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DOI：
10.1515/cclm-2021-0182
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发表时间：
2021-01-01
影响因子：
6.8
通讯作者：
Posteraro, Brunella
中科院分区：
文献类型：
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作者：
Menchinelli, Giulia;Bordi, Licia;Posteraro, Brunella
目的：与RT-PCR相比，抗原检测检测试剂盒（包括Lumipulse G SARS-CoV-2 Ag检测试剂盒）的性能较低，可能取决于特定的检测场景。方法：我们检测了594份来自COVID-19（RT-PCR循环阈值[Ct]值40）诊断个体的鼻咽拭子样本。RT-PCR阳性样本被分配到诊断、筛查或监测测试组。Lumipulse的检测限为1.2 x 10（4）SARS-CoV-2 RNA拷贝/mL，阳性一致率（PPA）为79.9%（155/194），阴性一致率为99.3%（397/400），而对于Ct值为
Objectives: Compared to RT-PCR, lower performance of antigen detection assays, including the Lumipulse G SARS-CoV-2 Ag assay, may depend on specific testing scenarios.Methods: We tested 594 nasopharyngeal swab samples from individuals with COVID-19 (RT-PCR cycle threshold [Ct] values 40) diagnoses. RT-PCR positive samples were assigned to diagnostic, screening, or monitoring groups of testing.Results: With a limit of detection of 1.2 x 10(4) SARS-CoV-2 RNA copies/mL, Lumipulse showed positive percent agreement (PPA) of 79.9% (155/194) and negative percent agreement of 99.3% (397/400), whereas PPAs were 100% for samples with Ct values of