title: Collection and characterization of samples for establishment of a serum repository for lyme disease diagnostic test development and evaluation.
abstract: Serological assays and a two-tiered test algorithm are recommended for laboratory confirmation of Lyme disease. In the United States, the sensitivity of two-tiered testing using commercially available serology-based assays is dependent on the stage of infection and ranges from 30% in the early localized disease stage to near 100% in late-stage disease. Other variables, including subjectivity in reading Western blots, compliance with two-tiered recommendations, use of different first- and second-tier test combinations, and use of different test samples, all contribute to variation in two-tiered test performance. The availability and use of sample sets from well-characterized Lyme disease patients and controls are needed to better assess the performance of existing tests and for development of improved assays. To address this need, the Centers for Disease Control and Prevention and the National Institutes of Health prospectively collected sera from patients at all stages of Lyme disease, as well as healthy donors and patients with look-alike diseases. Patients and healthy controls were recruited using strict inclusion and exclusion criteria. Samples from all included patients were retrospectively characterized by two-tiered testing. The results from two-tiered testing corroborated the need for novel and improved diagnostics, particularly for laboratory diagnosis of earlier stages of infection. Furthermore, the two-tiered results provide a baseline with samples from well-characterized patients that can be used in comparing the sensitivity and specificity of novel diagnostics. Panels of sera and accompanying clinical and laboratory testing results are now available to Lyme disease serological test users and researchers developing novel tests.
authors.affiliation: Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
authors.forename: Claudia R
authors.initials: CR
authors.lastname: Molins
authors.affiliation: Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Sexton
authors.affiliation: Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
authors.forename: John W
authors.initials: JW
authors.lastname: Young
authors.affiliation: Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, Colorado, USA.
authors.forename: Laura V
authors.initials: LV
authors.lastname: Ashton
authors.affiliation: Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Pappert
authors.affiliation: Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
authors.forename: Charles B
authors.initials: CB
authors.lastname: Beard
authors.affiliation: Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado, USA mms7@cdc.gov.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Schriefer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000592:standards*; D005260:Female; D006801:Humans; D008193:Lyme Disease / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D012698:Serologic Tests / Q000379:methods / Q000592:standards; D044967:Serum / Q000276:immunology*; D013048:Specimen Handling / Q000379:methods*; D014481:United States; D055815:Young Adult