Expanding Access to Biospecimens for Lyme Disease Test Development.

ABSTRACT

The laboratory diagnosis of Lyme disease relies upon serologic testing. A standard or modified two-tiered testing algorithm is used to enhance the accuracy of antibody detection. However, this approach suffers from a lack of sensitivity in early Lyme disease. Ongoing efforts to develop more sensitive antibody detection technologies and other diagnostic approaches are dependent upon the availability of quality-assured biospecimens linked to reliable clinical data. In this issue of the Journal of Clinical Microbiology, Horn et al. (E. J. Horn, G. Dempsey, A. M. Schotthoefer, U. L. Prisco, et al., J Clin Microbiol 58e00032-20, 2020, https//doi.org/10.1128/JCM.00032-20) described the development of the Lyme Disease Biobank. Clinically categorized case patients with early Lyme disease and healthy controls were identified (without laboratory diagnostic testing) from three sites where Lyme disease is endemic. Subjects provided whole blood and urine, which were processed and stored at a central biorepository. Whole blood, serum, and urine aliquots were prepared and are available to investigators developing laboratory diagnostics for Lyme disease. After obtaining samples, extensive laboratory testing was performed, including serologic and nucleic acid amplification testing for B. burgdorferi and other tick-borne pathogens. Direct detection methods yielded few positive results. Relative to the findings for another commonly used biorepository cohort, the results of this testing demonstrated a low seropositive rate, as determined by standard two-tiered testing. Additionally, relatively few subjects demonstrated seroconversion with testing of convalescent-phase samples. This clinical and serologically defined cohort of samples from Lyme disease and control cases from areas of Lyme disease endemicity offers an additional valuable resource for novel test development that includes alternate specimen types.