Performance of 45 Laboratories Participating in a Proficiency Testing Program for Lyme Disease Serology

摘要: Objective. —We show that significant interlaboratory and intralaboratory variations exist in Lyme disease proficiency testing. Design. —Six case-defined serum samples three from individuals with no history of were randomized four shipments distributed to 45 participating laboratories. Results. —Interlaboratory performances highly variable. Approximately 4% 21% laboratories failed identify correctly positive titers 512 or more using polyvalent immunoglobulin G conjugates. With lower levels anti— Borrelia burgdorferi antibody the sample, approximately 55% did not a serum. There was also striking inability many reproduce their results on split same individual. In addition, 2% 7% identified known exposure B as The false positivity rate increased 27% use conjugate. Conclusions. —Our indicate there is an urgent need for standardization current testing methodologies. Until national commitment made, serological will be questionable value diagnosis disease. ( JAMA . 1992;268:891-895)