INTERLABORATORY COMPARISON OF TEST-RESULTS FOR DETECTION OF LYME-DISEASE BY 516 PARTICIPANTS IN THE WISCONSIN-STATE-LABORATORY-OF-HYGIENE COLLEGE-OF-AMERICAN-PATHOLOGISTS PROFICIENCY TESTING PROGRAM

In 1991, we reported that 55% of laboratories participating in the Wis consin Proficiency Testing Program could not accurately identify serum samples from Lyme disease patients containing antibody against Borrel ia burgdorferi. The purpose of this study was to determine whether the accuracy of Lyme disease test results reported by approximately 500 p articipants in the Wisconsin State Laboratory of Hygiene/College of Am erican Pathologists Lyme Disease Survey had improved. From 1992 throug h 1994, 50 serum samples were sent to participants of the survey. Each laboratory received 28 serum samples from individuals with Lyme disea se according to the case definition of the Centers for Disease Control and Prevention and 22 serum samples from healthy individuals. Unfortu nately, the serodiagnosis of Lyme disease by participants had not impr oved. The specificity of the Lyme disease assays steadily decreased fr om approximately 95% to approximately 81% during the 3-year period of the survey. False-positive test results approached 55% with some of th e serum samples from healthy donors. A serum sample containing antibod y against Treponema pallidum was reported as positive by 70% of the pa rticipants. In addition, the sensitivity fluctuated between 93 and 75% , depending upon the conjugate used by the laboratories, These results suggest that stronger criteria must be applied for approving and cont inuing to approve commercially available kits for the serodiagnosis of Lyme disease.