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Serologic tests for Lyme disease. Interlaboratory variability
1Department of Pathology, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway.
Archives of Internal Medicine
|April 1, 1990
Summary
Serologic testing for Lyme disease shows significant variability between laboratories. Results indicate a need for standardized assays and reference materials for accurate Borrelia burgdorferi diagnosis.
Area of Science:
- Medical Diagnostics
- Infectious Diseases
- Immunology
Background:
- Serologic tests detecting antibodies to Borrelia burgdorferi are crucial for Lyme disease diagnosis.
- Current assays face challenges with insensitivity and significant interlaboratory variability.
Purpose of the Study:
- To quantify the interlaboratory variability in Borrelia burgdorferi antibody detection.
- To assess the reliability of serologic testing for Lyme disease diagnosis.
Main Methods:
- Serum samples from nine Lyme disease patients were distributed to nine reference laboratories.
- Each laboratory received two aliquots of the same serum samples, separated by a two-week interval.
Main Results:
- Observed wide variability in Borrelia burgdorferi antibody detection rates across laboratories (ranging from 8/18 to 18/18 specimens).
- Significant variability was also noted in the detection of specific IgM antibodies (ranging from 2/18 to 10/18 specimens).
- Eight instances of fourfold or greater titer changes were recorded between sample aliquots sent two weeks apart.
Conclusions:
- Results highlight the urgent need for assay standardization and national reference materials for Borrelia burgdorferi testing.
- Serologic test results alone should not be the sole basis for diagnosing Lyme disease.