Serological responses in Lyme disease: the influence of sex, age, and environment.

In the laboratory, the serodiagnosis of Lyme disease is a difficult decision, especially in early disease. The variability in the immune response to the Borrelia burgdorferi spirochete and the lack of specificity and sensitivity of commercial assays for the detection of antibodies in early disease have contributed to the difficulty of serodiagnosis. This study examines the serological data of over 20,000 serum specimens submitted for enzyme linked immunosorbent assay (ELISA) and/or Western Blot analysis to detect IgM and IgG antibodies to the Lyme spirochete. These samples were submitted to SmithKline Beecham Clinical Laboratories in Philadelphia from the five state region of New York, Pennsylvania, New Jersey, Delaware, and Massachusetts. These areas of the northeastern United States are considered endemic for infestation with the Borrelia burgdorferi spirochete and its vector, the deer tick. Samples were examined by positivity rate for ELISA and/or Western Blot Analysis (WBA). Specimens were broken down by age (greater than or equal to 13 years and less than 12 years) sex (male versus female), State (NY, NJ, PA, DE, MA), and by month of submission. Using the established criteria of the manufacturers for a positive response, these studies demonstrate an overall positivity rate for ELISA testing at 5.2 percent, while WBA alone had a positivity rate of 1.6 percent. Specimens examined by both ELISA and WBA had a positivity rate of 1.0 percent. Females > or = 13 years of age had the highest positivity rate of 8.5 percent on ELISA testing, while females < or = 12 years gave a positive reaction in 2.6 percent of the samples.(ABSTRACT TRUNCATED AT 250 WORDS)