The Lyme Disease Biobank - Characterization of 550 Patient and Control Samples from the East Coast and Upper Midwest of the United States.

Lyme disease (LD) is an increasing public health problem. Current laboratory testing is insensitive in early infection, the stage at which appropriate treatment is most effective in preventing disease sequela. The Lyme Disease Biobank (LDB) collects samples from individuals with symptoms consistent with early LD presenting with or without erythema migrans (EM) or an annular, expanding skin lesion, and uninfected individuals from endemic areas. Samples were collected from 550 participants (298 cases and 252 controls) according to IRB-approved protocols and shipped to a centralized biorepository. Testing was performed to confirm the presence of tick-borne pathogens by real-time PCR, and a subset of samples was tested for Borrelia burgdorferi by culture. Serology using the CDC9s standard two-tiered testing algorithm (STTTA) for LD was performed on all samples. LD diagnosis was supported by laboratory testing in 82 cases, including positive STTTA, PCR, culture, or 2 positive ELISA9s with EM >5 cm, while the remaining 216 cases had negative laboratory testing results. For the controls, 43 were positive on at least one of the tiers, and 6 were positive by STTTA. This collection highlights and reinforces the known limitations of serologic testing in early LD, with only 29% of individuals presenting with EM >5 cm yielding a positive result using the STTTA. Aliquots of whole blood, serum, and urine from clinically characterized patients with and without LD are available to investigators in academia and industry for evaluation or development of novel diagnostic assays for LD, to continue to improve upon currently available methods.