Table 1.
Prospective study comparing an ELISA that employs a 26-mer peptide from the sixth invariant region (C6) of the variable major protein-like sequence-expressed (VlsE) lipoprotein of the spirochete Borrelia burgdorferi with B. burgdorferi sonicate ELISA and Western blot for the serologic diagnosis of patients with Lyme disease and in control subjects.
| Proportion (%) of patients with positive result, by test(s) |
||||
|---|---|---|---|---|
| Sonicate 2-test approach
|
||||
| Variable | VlsE C6 peptide ELISA |
ELISA and Western blot IgM |
ELISA and Western blot IgG |
ELISA and Western blot IgM or IgG |
| Patients with Lyme disease | ||||
| Skin infection (stage 1) | ||||
| Erythema migrans without evidence of disseminated disease | ||||
| Acute | 7/36 (19) | 4/36 (11)a | 2/36 (6)b | 6/36 (17) |
|
| ||||
| Convalescent, after antibiotics | 17/36 (47) | 14/36 (39)a | 6/36 (17)b | 19/36 (53) |
|
| ||||
| Erythema migrans with evidence of disseminated diseasec | ||||
| Acute phase | 15/40 (38) | 15/40 (38)a | 6/40 (15)b | 17/40 (43) |
|
| ||||
| Convalescent phase (after receipt of antibiotics) | 25/40 (63) | 28/40 (70)a | 8/40 (20)b | 30/40 (75) |
|
| ||||
| Disseminated infection (stage 2) | ||||
| Acute neurologic or cardiac involvementd | 13/13 (100) | 11/13 (85) | 11/13 (85) | 13/13 (100) |
|
| ||||
| Persistent infection (stage 3) | ||||
| Arthritis or chronic neurologic involvemente | 31/31 (100) | 7/31 (23) | 31/31 (100) | 31/31 (100) |
|
| ||||
| Post-Lyme disease symptoms | 6/14 (43) | 7/14 (50) | 5/14 (36) | 10/14 (71) |
|
| ||||
| Patients with another illness | ||||
| And previous Lyme disease | 9/14 (64) | 1/14 (7) | 10/14 (71) | 11/14 (79) |
|
| ||||
| Not Lyme diseasef | 1/75 (1) | 0 | 0 | 0 |
|
| ||||
| Healthy subjects | ||||
| Area of Lyme disease endemicity | 4/86 (5) | 1/86 (1) | 1/86 (1) | 2/86 (2) |
|
| ||||
| Area in which Lyme disease is not endemic | 1/50 (2) | 0 | 0 | 0 |
With 2-tier testing, patients with erythema migrans who had evidence of disseminated disease had positive IgM responses significantly more often than did patients who lacked evidence of dissemination, both in acute-phase and convalescent-phase samples (in each instance, P = .02).
In patients with erythema migrans, the IgG VlsE C6 peptide ELISA became positive before IgG reactivity with ≥5 bands developed with 2-tier testing. In acute-phase samples, this difference approached statistical significance for patients who did not have evidence of dissemination (P = .15) and was statistically significant for patients who did have evidence of dissemination (P = .04). In comparison, the differences during the convalescent phase were still greater, both for patients who did not have evidence of dissemination (P = .003) and for those who did (P< .001).
Of the 40 patients, 25 had a PCR result positive for B. burgdorferi DNA in blood alone, 4 had multiple erythema migrans lesions alone, and 11 had both of these findings.
Of the 13 patients, 4 had meningitis and facial palsy (and in 1 case, radiculoneuritis), 4 had facial palsy alone, 1 had anterior optic neuritis, and 4 had high-degree atrioventricular nodal block. Of the 4 patients with heart block, 1 also had unilateral paralysis of the phrenic nerve, and another had radiculoneuritis. Seven of the 13 patients had erythema migrans, and 6 experienced flu-like symptoms several weeks prior to the onset of neurologic or cardiac abnormalities. They did not receive antibiotic therapy at that time, but they were treated successfully when they had neurologic or cardiac involvement.
Of the 31 patients, 30 had arthritis (in 1 case accompanied by radiculoneuropathy), and 1 patient had radiculoneuropathyalone. Six patients had erythema migrans, and 5 experienced flu-like symptoms months prior to the onset of arthritis or radiculoneuropathy; in the remaining 20 patients, arthritis was the initial manifestation of the illness. Twelve (40%) of the 30 patients with arthritis had a result positive for B. burgdorferi DNA in joint fluid. One patient with erythema migrans was treated with oral amoxicillin for 30 days, but the remaining patients did not receive antibiotics prior to the onset of joint or neurologic abnormalities.
Includes 37 patients with chronic fatigue syndrome or fibromyalgia, 19 with rheumatic diseases (such as rheumatoid arthritis or psoriatic arthritis), 11 with neurologic illnesses (including multiple sclerosis), 7 with other infections, and 1 with T cell lymphoma.