August 8, 1990

Diagnostic Tests for Lyme Disease-Reply

Author Affiliations

DIANON Systems Inc Stratford, Conn

DIANON Systems Inc Stratford, Conn

JAMA. 1990;264(6):693. doi:10.1001/jama.1990.03450060038016

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In Reply.—  Drs Feder and Rosenthal describe the clinical history of a patient who had an adverse drug reaction from treatment for a presumed diagnosis of Lyme borreliosis. From this evidence they conclude that the diagnostic criteria for this disease should be based on clinical evidence, with laboratory testing playing a secondary role.This approach to the diagnosis of Lyme borreliosis will find general concurrence in both the clinical community and those organizations that provide laboratory testing services.The further conclusion, that the urine antigen test is uninterpretable, may come as a surprise to the clinicians currently using the results of this assay, along with clinical evidence, in the treatment of patients with Lyme borreliosis. Our experience covers nearly 11000 determinations from 8000 patients tested for Lyme borreliosis—for 6000 of whom simultaneous clinical data exist. Approximately 15% of our specimens are positive. False-positive results, as in most laboratory assays,