Improved Serodiagnostic Performance for Lyme Disease by Use of Two Recombinant Proteins in Enzyme-Linked Immunosorbent Assay Compared to Standardized Two-Tier Testing

摘要

Lyme disease (LD) continues to be the most common vector-borne disease in North America (1), with increasing incidence in the United States and Canada (2). The primary agent of LD in North America is the spirochete Borrelia burgdorferi sensu stricto, which is transmitted chiefly by the tick vectors Ixodes scapularis and Ixodes pacificus (3). The diagnosis of LD is based on patient history, clinical presentation, and serology (1, 3). The observation of erythema migrans (EM), which is present in 70 to 80% of early LD patients (1, 3), is very important in the detection and diagnosis of this stage of disease and is considered pathognomonic in areas of endemicity (4). Direct detection of the spirochete, either by culture or by PCR amplification of Borrelia genes, is often unreliable due to the small number of organisms present in any sample or stage of infection (2, 3). Therefore, serology remains the most important confirmatory step in the diagnosis of LD (5). As with many infectious diseases, early detection and confirmation of LD are difficult to establish, but they are crucial in the management of the disease. Early treatment for LD can mitigate or even prevent the complications of late-stage illness, which can adversely affect the heart, nervous system, and joints and can persist for months or even years (6).