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Key Objectives:
This roundtable discussion will review issues surrounding existing diagnostic criteria for Lyme disease, describe the potential uses of new algorithms and novel diagnostics, and discuss the opportunities for changes to diagnostic criteria for the case definition.
Brief Summary:
The current CSTE case definition for Lyme disease includes both clinical and laboratory criteria. Laboratory requirements are based upon CDC recommendations for two-tiered serologic testing established in 1995. The two-tiered approach consists of a first tier immunoassay (ELISA/EIA), followed by Western blots for IgG or IgM anti-Borrelia burgdorferi antibodies if the first test is positive or indeterminate. The performance parameters of these tests vary by stage of illness and the results can be difficult to interpret. Recently, newer diagnostic testing approaches have been marketed, though few have been properly validated or described in the scientific literature, and none have been cleared by the U.S. Food and Drug Administration (FDA). The results of these tests are being reported to state public health agencies more frequently each year, and are further complicating case classification. One new approach that has received support in the scientific literature is the use of two currently available, FDA-approved, EIA tests used sequentially. This new algorithm may offer advantages over the currently recommended two-tiered testing protocol. Potential benefits include simplicity, objectivity, improved sensitivity in early disease, independence from disease duration, avoidance of blotting, and decreased cost. These published findings must be independently reproduced before any of these new approaches can be approved by FDA and recommended by CDC. Reliance on FDA clearance for diagnostic criteria would greatly simplify the case definition and reduce the need for future revisions. This roundtable discussion will review issues surrounding existing diagnostic criteria for Lyme disease, describe the potential uses of new algorithms and novel diagnostics, and discuss the opportunities for changes to diagnostic criteria for the case definition.