Multicenter Clinical Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Using Zeus Scientific Commercial Assays
Maroun M. Sfeir, Jennifer K. Meece, Elitza S. Theel, Dane Granger, Thomas R. Fritsche, Allen C. Steere, John A. Branda
Abstract
Modified two-tiered testing (MTTT) algorithms for Lyme disease (LD), which involve the sequential use of orthogonal enzyme immunoassays (EIAs) without immunoblotting, are acceptable alternatives to standard two-tiered testing (STTT; EIA followed by immunoblots) provided the EIAs have been FDA-cleared for this intended use. We evaluated four Zeus Scientific LD EIAs used in two distinct MTTT algorithms for FDA review.
Topics & Concepts
Lyme diseaseClearanceAlgorithmMedicineZEUS (particle detector)Computer scienceVirologyPhysicsOpticsDeep inelastic scatteringInelastic scatteringUrologyScatteringVector-borne infectious diseasesInsect and Pesticide ResearchMosquito-borne diseases and control