The current standard for laboratory diagnosis of Lyme disease in the United States is serologic detection of antibodies against Borrelia burgdorferi (Bb). The Centers for Disease Control and Prevention recommends a two-tiered testing algorithm, however this scheme has limited sensitivity in detecting early Lyme disease. Thus, there is a need to improve diagnostics for Lyme disease at the early stage when antibiotic treatment is highly efficacious.
We examined novel and established antigen markers to develop a multiplex panel that identifies early infection using the combined sensitivity of multiple markers, while simultaneously maintaining high specificity by requiring a positive test at two markers. Ten markers were selected from our initial analysis of 62 Bb surface proteins and synthetic peptides by assessing binding of IgG and IgM to each in a training set of Lyme disease patient samples and controls.
In a validation set, this 10-antigen panel identified a higher proportion of early Lyme disease patients as positive at the baseline or post-treatment visit compared to two-tiered testing (87.5% and 67.5% respectively, P<0.05). Equivalent specificities of 100% were observed in 26 healthy controls. Upon further analysis, positivity on the novel 10-antigen panel was associated with longer illness duration and multiple erythema migrans.
The improved sensitivity and comparable specificity of our 10-antigen panel compared to two-tiered testing in detecting early Bb infection indicates that multiplex analysis, featuring the next generation of markers, could advance diagnostic technology to better aid clinicians in diagnosing and treating early Lyme disease.
Source: By LJ Lahey, Panas MW, Mao R, Delanoy M, Flanagan J, Binder SR, Rebman AW, Montoya JG, Soloski MJ, Steere AC, Dattwyler RJ, Arnaboldi PM,Aucott JN, Robinson WH. Development of a multi-antigen panel for improved detection of Borrelia burgdorferi infection in early Lyme disease. J Clin Microbiol. (2015 Oct 7). pii: JCM.02111-15. [Epub ahead of print]