title: The Accuracy of Diagnostic Tests for Lyme Disease in Humans, A Systematic Review and Meta-Analysis of North American Research.
abstract: There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme disease agent (Borrelia burgdorferi sensu stricto). There are many diagnostic tests for LD available in North America, all of which have some performance issues, and physicians are concerned about the appropriate use and interpretation of these tests. The objective of this systematic review is to summarize the North American evidence on the accuracy of diagnostic tests and test regimes at various stages of LD. Included in the review are 48 studies on diagnostic tests used in North America published since 1995. Thirteen studies examined a two-tier serological test protocol vs. clinical diagnosis, 24 studies examined single assays vs. clinical diagnosis, 9 studies examined single immunoblot vs. clinical diagnosis, 7 studies compared culture or PCR direct detection methods vs. clinical diagnosis, 22 studies compared two or more tests with each other and 8 studies compared a two-tiered serological test protocol to another test. Recent studies examining the sensitivity and specificity of various test protocols noted that the Immunetics® C6 B. burgdorferi ELISA™ and the two tier approach have superior specificity compared to proposed replacements, and the CDC recommended western blot algorithm has equivalent or superior specificity over other proposed test algorithms. There is a dramatic increase in test sensitivity with progression of B. burgdorferi infection from early to late LD. Direct detection methods, culture and PCR of tissue or blood samples were not as sensitive or timely compared to serological testing. It was also noted that there are a large number of both commercial (n = 42) and in-house developed tests used by private laboratories which have not been evaluated in the primary literature.
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Guelph, Ontario, Canada.
authors.forename: Lisa A
authors.identifier: http://orcid.org/0000-0003-4887-5124
authors.initials: LA
authors.lastname: Waddell
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Guelph, Ontario, Canada.
authors.forename: Judy
authors.initials: J
authors.lastname: Greig
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Guelph, Ontario, Canada.
authors.forename: Mariola
authors.initials: M
authors.lastname: Mascarenhas
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Guelph, Ontario, Canada.
authors.forename: Shannon
authors.initials: S
authors.lastname: Harding
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
authors.forename: Robbin
authors.initials: R
authors.lastname: Lindsay
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, St. Hyacinthe, Quebec, Canada.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Ogden
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D025065:Borrelia burgdorferi / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification; D004269:DNA, Bacterial / Q000235:genetics / Q000378:metabolism; D016208:Databases, Factual; D003955:Diagnostic Tests, Routine / Q000592:standards*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008193:Lyme Disease / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012698:Serologic Tests
chemical_list: D000907:Antibodies, Bacterial; D004269:DNA, Bacterial