Context Diagnosis of infection with Borrelia burgdorferi, the cause of Lyme
disease (LD), has been impeded by the lack of effective assays to detect a
ctive infection.
Objective To determine whether B burgdorferi-specific immune complexes are
detectable during active infection in LD.
Design, Setting, and Patients Cross-sectional analysis of serum samples fro
m 168 patients fulfilling Centers for Disease Control and Prevention survei
llance criteria for LD and 145 healthy and other disease controls conducted
over 8 years. Tests were performed blinded.
Main Outcome Measure Detection of B burgdorferi immune complexes by enzyme-
linked immunosorbent assay and Western blot.
Results The B burgdorferi immune complexes were found in 25 of 26 patients
with early seronegative erythema migrans (EM) LD; 105 of 107 patients with
seropositive EM LD; 6 of 10 patients who were seronegative with culture-pos
itive EM; 0 of 12 patients who were treated and recovered from LD; and 13 o
f 13 patients with neurologic LD without EM. Among 147 controls, B burgdorf
eri immune complex was found in 0 of 50 healthy individuals; 0 of 40 patien
ts with persistent fatigue; 0 of 7 individuals with frequent tick exposure;
and 2 of 50 patients with other diseases.
Conclusion These data suggest that B burgdorferi immune complex formation i
s a common process in active LD. Analysis of the B burgdorferi immune compl
exes by a simple technique has the potential to support or exclude a diagno
sis of early as well as active LD infection.