Peter Tugwell, MD, MSc; Allen Steere, MD; Arthur Weinstein, MD
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Tugwell P., Steere A., Weinstein A.; Guidelines for the Clinical Diagnosis of Lyme Disease. Ann Intern Med. 1998;129:423. doi: 10.7326/0003-4819-129-5-199809010-00019
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Published: Ann Intern Med. 1998;129(5):423.
Dr. Liegner and Ms. Kochevar and Dr. McCaulley raise the issue of the frequency and implications of false-negative results on laboratory tests in patients with true Lyme disease.
Liegner and Kochevar suggest that such patients may have negative ELISA results but positive or suspicious Western blots, claiming that this differs from the experience with HIV testing. In good laboratories with careful calibration of ELISA, this has not been the case. In these laboratories, ELISA almost always yields positive or indeterminate results in cases of true Lyme disease. Liegner and Kochevar state that the presence of one or two high specific bands may be a vital clue to diagnosis. The problem is that the bands are not completely specific. For example, approximately 25% of normal controls have the 23-kD band. Carefully designed studies with well-characterized patients and appropriate control groups have shown acceptable levels of diagnostic specificity only when multiple bands of specific molecular weights are required for diagnosis.
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