莱姆病
免疫分析
医学
莱姆
宙斯(粒子探测器)
算法
病毒学
伯氏疏螺旋体
免疫学
抗体
计算机科学
物理
深非弹性散射
非弹性散射
光学
散射
作者
Elizabeth Lee-Lewandrowski,Sarah E. Turbett,John A. Branda,Kent Lewandrowski
出处
期刊:American Journal of Clinical Pathology
[Oxford University Press]
日期:2023-08-07
卷期号:160 (6): 599-602
摘要
Recently modified 2-tier testing (MTTT) algorithms using 2 enzyme immunoassays (EIAs) as opposed to an EIA followed by immunoblot have been approved by the US Food and Drug Administration (FDA) for the screening and confirmation of Lyme disease. The Quidel Sofia Lyme fluorescent immunoassay is a rapid lateral-flow method that can be performed in real time, permitting on-demand testing. We evaluated the performance of the Sofia assay as a first-tier test in an MTTT algorithm.We compared the Sofia Lyme test with the Zeus ELISA Borrelia VlsE1/pepC10 lgG/IgM test, followed by the Zeus monovalent IgM/IgG EIA as the confirmatory test.When used as a first-tier test compared with a standard Zeus MTTT assay, the positive percentage agreement was 91.4%% (95% CI, 77.6%-97.0%). The negative percentage agreement was 100% (95% CI, 94.0%-100%). The overall agreement was 98.3% (95% CI, 94.2%-99.4%). κ = 0.945, indicating "almost perfect agreement."The Sofia Lyme test performs well compared with an FDA-approved MTTT.
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