Our understanding of Lyme disease relies primarily on clinical observations. The diagnosis is typically made with clinical criteria, and the effectiveness of antibiotic therapy is determined by clinical end points. Although this approach has served both patients and physicians well, important questions persist that cannot be answered by the clinical approach alone. For instance, if previously established clinical criteria are required for the diagnosis, how can atypical syndromes be evaluated as possibly due to Lyme disease? Attempts to define both the full clinical spectrum of Lyme disease and the means of accurately diagnosing the illness according to clinical criteria set up a diagnostic Catch-22 that cannot be resolved without a way of confirming the presence of Borrelia burgdorferi.
The New England Journal of Medicine
N Engl J Med. 1994 Jan 27;330(4):282-3.