A first-tier rapid assay for the serodiagnosis of Borrelia burgdorferi infection.

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Abstract
LYME DISEASE is a significant public health concern and is currently the most common vector-borne infectious disease in the United States, where its primary tick vector, Ixodes scapularis, is endemic.1 Caused by the spirochete Borrelia burgdorferi, this infectious disease may affect multiple organ systems. Except erythema migrans (EM), none of the clinical manifestations of Lyme disease are pathognomonic. In fact, many can be observed in other illnesses. In the absence of observed EM, the diagnosis of Lyme disease is confirmed by the detection of a humoral immune response to B burgdorferi in patients with objective findings suggestive of the disease.2-8 Adoption of a conditional 2-step approach to the serodetection of anti–B burgdorferi antibodies has markedly improved the accuracy of laboratory diagnosis.9 The first step of this 2-step approach is performance of an enzyme-linked immunosorbent assay (ELISA) or immunofluorescent assay; if the results of the assay are positive or equivocal, the second step, performance of a Western blot, follows. Although this 2-step approach improves the accuracy of Lyme disease testing, it has added significantly to the time it takes to finish the laboratory evaluation of patients suspected of having Lyme disease.

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