Quality control assessment of Canadian laboratories testing for Lyme disease.

In June 1990 a quality control assessment was undertaken of Canadian public health laboratories testing for antibodies to Borrelia burgdorferi, the etiological agent of Lyme disease. Twenty sera were distributed to nine laboratories, including 12 obtained from patients in Lyme endemic areas and presumed to be serological positives, and eight prescreened negative controls. Seventeen serological reports were submitted, comprising nine enzyme-linked immunosorbent assays (elisa), six immunofluorescent assays and two Western blot assessments. Antibodies were detected in 11 of the 12 sera which had been presumed to be positive. Assuming 11 positive sera had been submitted, the test sensitivities varied from 88.9 to 100% by elisa, and 54.5 to 90.1% by immunofluorescent assay. Specificities were 100% for all but one elisa and one immunofluorescent assay assessment. The results indicate a satisfactory performance by elisa but a need for upgrading or replacement of some immunofluorescent assay tests.