Enrollment | Overview
Between June 2015 and December 2021, Pedi Lyme Net enrolled more than 4,000 children undergoing evaluation for Lyme disease, with research biosample collection from the majority (>90%).
The enrolled patients span the clinical spectrum with symptoms compatible with early, early disseminated, and late Lyme disease. The median patient age was 9 years (interquartile range 6 to 13 years). We have also recruited over 375 healthy control children from Pedi Lyme Net EDs who are undergoing intravenous line placement.
Lyme Disease Case Definition
Our research Lyme disease case definition consists of either a physician-diagnosed erythema migrans (EM) lesion or a positive two-tiered serology in a patient with compatible symptoms. We utilize a commercially available first-tier C6 enzyme immunoassay (EIA), followed by a supplemental immunoblot for children with a positive or equivocal first-tier test. Children undergoing clinical evaluation for Lyme disease who do not meet our case definition are classified as Lyme “mimics.” Approximately 20% of the enrolled children have confirmed Lyme disease.