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Canadian Journal of Infectious Diseases
Volume 6, Issue 2, Pages 90-95
Original Article

Intra- and Interlaboratory Reproducibility of an ELISA Serological Test for Lyme Disease

Martin C Tammemagi,1 John W Frank,1,2 Michael LeBlanc,1,2 and Harvey Artsob1,3

1Graduate Department of Community Health, University of Toronto, Toronto, Canada
2Department of Preventative Medicine and Biostatistics, University of Toronto, Toronto, Canada
3Laboratory Centre for Disease Control, Ottawa, Ontario, Canada

Received 16 June 1994; Accepted 21 September 1994

Copyright © 1995 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Objectives: Lyme disease has been increasingly diagnosed throughout North America since the late 1970s. The clinical diagnosis and epidemiological monitoring of Lyme disease are aided by serological testing for the etiological agent, Borrelia burgdorferi. Numerous authorities have questioned the reproducibility of these serological tests. This study assessed the intra- and interlaboratory reproducibility of an elisa used to aid in the diagnosis of Lyme disease.

Methods: Twenty-seven sera from cases and noncases were tested by three laboratories. Two of the laboratories repeated the tests once. These testings were part of the 1991 quality control assessment of provincial laboratories carried out by the Laboratory Centre for Disease Control (lcdc), Ottawa.

Results: The mean weighted kappa statistics were 0.87 for interlaboratory comparisons and 0.89 for intralaboratory comparisons.

Conclusions: Overall, the elisa assessed in this study demonstrated good to excellent intra- and interlaboratory reproducibility in the lcdc 1991 quality control assessment when the data were assessed in the categorical scale using the weighted kappa statistic. Generalization of these findings to clinical laboratory settings must be done with caution.