A Dutch nationwide evaluation of serological assays for detection of Borrelia antibodies in clinically well-defined patients.
Numerous tests for the detection of antibodies against Borrelia burgdorferi are commercially available. Manufacturer-derived data invariably report a high sensitivity and specificity, but comparative studies demonstrate large differences in clinical practice, especially with regard to specificity. We retrospectively collected data from validation studies for B. burgdorferi antibody assays from 8 laboratories in the Netherlands. The total number of samples was 809. Samples were selected based on clinical and laboratory parameters. We included samples from patients with erythema migrans, acrodermatitis chronicum atrophicans, and neuroborreliosis; cross-reactivity controls; and healthy controls. Data are presented from 10 enzyme-linked immunosorbent assays and 5 immunoblots. For manifestations of B. burgdorferi infection with short disease duration, the positivity rate of the assays varied significantly. In patients with long disease duration, the positivity rate differed only marginally. In cross-reactivity controls, there was significant variation in the reactivity rate. The majority of false-positive reactions are of the IgM isotype.
Department of Medical Microbiology and Infection Control, VU University Medical Centre, Amsterdam, The Netherlands. Electronic address: w.ang@vumc.nl.
C W
CW
Ang
Center for Infectious Diseases, Izore, Leeuwarden, The Netherlands.
A H
AH
Brandenburg
Department of Medical Microbiology, Centre of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands.
N D
ND
van Burgel
Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
H A
HA
Bijlmer
Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
T
T
Herremans
Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.
F
F
Stelma
Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
F Verduyn
FV
Lunel
OLVG/Public Health Laboratory, Amsterdam, The Netherlands.
A P
AP
van Dam
D000907:Antibodies, Bacterial / Q000097:blood*; D025065:Borrelia burgdorferi / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005189:False Positive Reactions; D006801:Humans; D015151:Immunoblotting / Q000379:methods; D008193:Lyme Disease / Q000175:diagnosis*; D009426:Netherlands; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*
D000907:Antibodies, Bacterial
Borrelia; ELISA; Lyme; Quality control; Serology