“…An ELISA (IR6) using a peptide derived from the VlsE protein of Borrelia has demonstrated greater specificity in the detection of Lyme disease than whole-cell ELISAs and has been approved for use by the FDA (19,23). However, C6, the peptide derived from VlsE, does not bind IgM particularly well, is derived from an antigen that is expressed only after infection is established (fewer than 1% of bacteria in the tick express VlsE, and transcription of the gene is suppressed prior to transmission of the bacteria), and the IR6 region of VlsE from which the peptide is derived has shown a greater degree of variability than originally thought (19,(23)(24)(25)(26). Though the IR6 assay represents a significant improvement, in terms of specificity, compared to the whole-cell ELISA (27), these concerns have precluded the use of the IR6 assay as a stand-alone diagnostic test for early Lyme disease.…”