Department of Pathology, Division of Clinical Laboratories and Molecular Medicine, Massachusetts General Hospital.
Harvard Medical School, Boston, MA, US.
Am J Clin Pathol. 2023 Dec 1;160(6):599-602. doi: 10.1093/ajcp/aqad094.
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.
最近，美国食品和药物管理局（FDA）批准了使用两种酶联免疫吸附测定（EIAs）而非 EIA 后免疫印迹的改良 2 级检测（MTTT）算法，用于莱姆病的筛查和确认。Quidel Sofia 莱姆荧光免疫测定是一种快速侧向流动方法，可实时进行，允许按需检测。我们评估了 Sofia 测定作为 MTTT 算法中一级检测的性能。
我们将 Sofia Lyme 试验与 Zeus ELISA Borrelia VlsE1/pepC10 lgG/IgM 试验进行了比较，然后使用 Zeus 单价 IgM/IgG EIA 作为确认试验。
与标准 Zeus MTTT 检测相比，当用作一级检测时，阳性百分比符合率为 91.4%（95%CI，77.6%-97.0%）。阴性百分比符合率为 100%（95%CI，94.0%-100%）。总体符合率为 98.3%（95%CI，94.2%-99.4%）。κ=0.945，表明“几乎完美一致”。
Sofia Lyme 试验与 FDA 批准的 MTTT 相比表现良好。
