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Published on: March 29, 2010
Performance of 45 laboratories participating in a proficiency testing program for Lyme disease serology
L L Bakken1, K L Case, S M Callister
1Wisconsin State Laboratory of Hygiene, University of Wisconsin, Madison 53706.
Insights
Proficiency testing for Lyme disease reveals significant variations in laboratory accuracy. Standardizing diagnostic methods is crucial for reliable Lyme disease serological testing and accurate patient diagnosis.
Area of Science:
- Medical Diagnostics
- Infectious Disease Serology
- Clinical Laboratory Science
Background:
- Lyme disease diagnosis relies heavily on serological testing.
- Proficiency testing is essential for evaluating laboratory performance and ensuring diagnostic accuracy.
Purpose of the Study:
- To assess interlaboratory and intralaboratory variations in Lyme disease proficiency testing.
- To identify inconsistencies in the accurate detection of Lyme disease antibodies.
Main Methods:
- Six case-defined Lyme serum samples and three control serum samples were distributed to 45 laboratories.
- Samples were randomized across four shipments for blinded testing.
Main Results:
- High variability in laboratory performance was observed, with significant interlaboratory and intralaboratory discrepancies.
- Failure to correctly identify positive samples ranged from 4% to 21% for high titers and up to 55% for lower antibody levels.
- False positive rates varied from 2% to 7% with polyvalent conjugates and increased to 27% with immunoglobulin G conjugates.
Conclusions:
- Urgent need for standardization of Lyme disease serological testing methodologies.
- Current testing lacks reliability, questioning its diagnostic value without standardized protocols.
- National commitment to standardization is required for dependable Lyme disease diagnosis.
Objective:
We show that significant interlaboratory and intralaboratory variations exist in Lyme disease proficiency testing.
Design:
Six case-defined Lyme serum samples and three serum samples from individuals with no history of Lyme disease were randomized in four shipments and distributed to 45 participating laboratories.
Results:
Interlaboratory and intralaboratory performances were highly variable. Approximately 4% to 21% of laboratories failed to identify correctly positive serum samples with titers of 512 or more using polyvalent serum or immunoglobulin G conjugates. With lower levels of anti-Borrelia burgdorferi antibody in the serum sample, approximately 55% of participating laboratories did not identify a case-defined serum. There was also a striking inability of many laboratories to reproduce their results on split samples from the same individual. In addition, 2% to 7% of laboratories identified serum samples from individuals with no known exposure to B burgdorferi as positive using polyvalent serum. The false positivity rate increased to 27% with the use of immunoglobulin G conjugate.
Conclusions:
Our results indicate that there is an urgent need for standardization of current testing methodologies. Until a national commitment is made, serological testing for Lyme disease will be of questionable value for the diagnosis of the disease.
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