A-267 Evaluation of the Quidel Sofia 2 Rapid Lyme Test in a Modified Two-tier Testing Protocol
نویسندگان
چکیده
Abstract Background Several Modified two-tier testing algorithms (MTTT) for Lyme disease involving sequential enzyme immunoassays (EIA) have been approved by the FDA as an alternative to conventional two-tiered using EIA followed immunoblot. The MTTT are reported be more sensitive than algorithm’s especially in early disease. Quidel Sofia 2 assay utilizes lateral flow with fluorescence detection (FIA) providing a rapid on-demand instrument-read central laboratory batch mode We compared first-tier test algorithm Zeus Scientific VlsE1/pepC10 IgG/IgM immunoassay monovalent IgM and IgG confirmatory test. Methods Serum specimens (n = 179) were obtained from consecutive samples sent our clinical serology testing. For tested lgG/IgM FIA assay. Positive or equivocal tests then Results positive percent agreement was 100%, negative 97.9 % overall of 98.3%. Kappa statistic 0.945 (95% confidence interval 0.883–1.000 indicating “almost perfect” agreement). Conclusion performs well when algorithm. Obtaining evaluate serologic can challenging. Our data should prove useful facilities considering use
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ژورنال
عنوان ژورنال: Clinical Chemistry
سال: 2023
ISSN: ['0009-9147', '1530-8561']
DOI: https://doi.org/10.1093/clinchem/hvad097.235