title: Evaluation of two commercially available rapid diagnostic tests for Lyme borreliosis.
abstract: The diagnosis of Lyme disease is very complicated and a single diagnostic method cannot exclude infection. We assessed the performance of two commercially available Borrelia burgdorferi rapid diagnostic tests (RDT) in comparison to multiple laboratory-based diagnostic assays using specimens with a gradually increasing probability of Borrelia infection. Based on 200 specimens, the analytical sensitivities for IgG and IgM were 18 and 23% for the Lyme RDT and 24 and 32% for the Borreliose Complete RDT. The sensitivity for detecting diagnosed Lyme borreliosis cases was low (26% Lyme RDT and 32% with the Borreliose Complete RDT respectively), whereas the specificity was good (85% Lyme RDT and 88% Borreliose Complete). Based on this evaluation, the performance of RDTs in detecting Lyme borreliosis appeared to be below that of laboratory-based diagnostics.
authors: European Program for Public Health Microbiology Training, European Centre for Disease Prevention and Control, Stockholm, Sweden. pieterwsmit@gmail.com.|Department of Infectious Disease Surveillance and Control, National Institute for Health and Welfare, Helsinki, Finland. pieterwsmit@gmail.com.
authors: P W
authors: PW
authors: Smit
authors: Faculty of Medicine, University of Helsinki, Helsinki, Finland.|Helsinki University Central Hospital Laboratory, Helsinki, Finland.
authors: S
authors: S
authors: Kurkela
authors: Department of Infectious Disease Surveillance and Control, National Institute for Health and Welfare, Helsinki, Finland.
authors: M
authors: M
authors: Kuusi
authors: Faculty of Medicine, University of Helsinki, Helsinki, Finland.|Helsinki University Central Hospital Laboratory, Helsinki, Finland.|Faculty of Veterinary Medicine, University of Helsinki, Helsinki, Finland.
authors: O
authors: O
authors: Vapalahti
mesh_terms: D025065:Borrelia burgdorferi / Q000276:immunology*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D008193:Lyme Disease / Q000175:diagnosis*; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D007074:Immunoglobulin G; D007075:Immunoglobulin M