Citations 1
Multicenter Clinical Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Using Zeus Scientific Commercial Assays
Sfeir, Maroun M. , Meece, Jennifer K. , Theel, Elitza S. , Granger, Dane, Fritsche, Thomas R., Branda, John A. , Branda, John A , Steere, Allen C.
Journal of Clinical Microbiology | April 14, 2022 | Volume: 60 | Issue: 5 | Pages: No page available
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.