The diagnosis of
Lyme disease should be based on objective clinical signs and symptoms. In a clinical study, we have evaluated whether the recommended two-step approach for serodiagnosis of
Lyme disease is useful in daily clinical practice and can influence clinical decision making.
The signs and symptoms of patients with ongoing musculoskeletal complaints, assumed by their referring physician or themselves to be attributable to active or chronic
Lyme disease, and of patients diagnosed as having
Lyme disease, were evaluated. On the basis of clinical evaluation only, patients were classified into three groups: previous
Lyme disease, active
Lyme disease and no
Lyme disease. Antibodies to Borrelia burgdorferi were determined by means of an enzyme-linked immunosorbent assay (ELISA), followed, when positive, by immunoblotting.
One hundred and three patients (41 males and 62 females, mean age 48.7 yr) participated in the study. Of the 49 patients classified as previous
Lyme disease, 25 (51%) had antibodies to B. burgdorferi. All 10 patients with active
Lyme disease had positive antibodies and 12 of the 44 patients (27%) classified as no
Lyme disease had positive antibodies. No statistically significant differences were found between the percentage of positive immunoblots from patients with previous
Lyme disease (72%) and patients with active
Lyme disease (100%). In the group of no
Lyme disease, five out of 12 patients had a negative immunoblot. Concerning serological testing, immunoblotting could have added additional information. However, immunoblotting did not influence clinical decision making in this group of patients.
Immunoblotting did not influence clinical decision making for the 47 patients with antibodies to B. burgdorferi in this study.