Table 5.
Prevalence of anti-Borrelia antibodies by two-tiered testing (ELISA-immunoblot) among patients with erythema migrans or post-treatment Lyme symptoms (PTLS).
| First-Tier ELISA | Second-Tier Immunoblot a | % Positive (95% Confidence Limits) b | % Negative (95% Confidence Limits) c | |||||
|---|---|---|---|---|---|---|---|---|
| Erythema Migrans | PTLS-c (n = 19) |
PTLS-p ≤2 Years (n = 148) |
PTLS-p >2 Years (n = 168) |
Community Controls (n = 41) |
||||
| All (n = 32) |
≤30 Days d (n = 16) |
>30 Days d (n = 16) |
||||||
| C6 ELISA | WB IgG | 34.4 *** (18.6, 53.2) |
37.5 ** (15.2, 64.6) |
31.3 (11.0, 58.7) |
36.8 (16.3, 61.6) |
23.0 (16.5, 30.6) |
10.1 (6.0, 15.7) |
97.6 (87.1, 99.9) |
| VlsE IgG | 68.8 (50.0, 83.9) |
81.3 (54.4, 96.0) |
56.3 (29.9, 80.2) |
42.1 (20.3, 66.5) |
25.0 (18.3, 32.8) |
11.3 (6.9, 17.1) |
97.6 (87.1, 99.9) |
|
| WB IgM | 56.3 * (37.7, 73.6) |
62.5 (35.4, 84.8) |
50.0 (24.7, 75.3) |
0.0 (0, 17.6) |
7.4 *** (3.8, 12.9) |
0.0 *** (0.0, 2.2) |
100 (91.4, 100.0) |
|
| WB IgG/IgM e | 78.1 (60.0, 90.7) |
87.5 (61.7, 98.4) |
68.8 (41.3, 89.0) |
36.8 (16.3, 61.6) |
24.3 * (17.7, 32.1) |
10.1 (6.0, 15.7) |
97.6 (87.1, 99.9) |
|
| EUROLINE-RN-AT IgG | 75.0 (56.6, 88.5) |
87.5 (61.7, 98.4) |
62.5 (35.4, 84.8) |
36.8 (16.3, 61.6) |
27.0 (20.1, 34.9) |
13.1 (8.4, 19.2) |
95.1 (83.5, 99.4) |
|
| EUROLINE-RN-AT IgM | 78.1 (60.0, 90.7) |
93.8 (69.8, 99.8) |
62.5 (35.4, 84.8) |
15.8 (3.4, 39.6) |
16.9 (11.2, 23.9) |
7.1 (3.7, 12.1) |
97.6 (87.1, 99.9) |
|
| EUROLINE-RN-AT IgG/IgM e | 87.5 (71.0, 96.5) |
100.0 (79.4, 100.0) |
75.0 (47.6, 92.7) |
42.1 (20.3, 66.5) |
29.1 (21.9, 37.1) |
13.7 (8.9, 19.8) |
92.7 (80.1, 98.5) |
|
| Anti-Borrelia ELISA IgG plus VlsE/IgM f | WB IgG | 34.4 *** (18.6, 53.2) |
37.5 ** (15.2, 64.6) |
31.3 (11.0, 58.7) |
42.1 (20.3, 66.5) |
25.7 (18.9, 33.5) |
13.1 (8.4, 19.2) |
97.6 (87.1, 99.9) |
| VlsE IgG | 68.8 (50.0, 83.9) |
81.3 (54.4, 96.0) |
56.3 (29.9, 80.2) |
42.1 (20.3, 66.5) |
25.7 (18.9, 33.5) |
11.9 (7.4, 17.8) |
97.6 (87.1, 99.9) |
|
| WB IgM | 56.3 * (37.7, 73.6) |
62.5 (35.4, 84.8) |
50.0 (24.7, 75.3) |
0.0 * (0, 17.6) |
7.4 *** (3.8, 12.9) |
0.6 *** (0, 3.3) |
97.6 (87.1, 99.9) |
|
| WB IgG/IgM e | 78.1 (60.0, 90.7) |
87.5 (61.7, 98.4) |
68.8 (41.3, 89.0) |
42.1 (20.3, 66.5) |
27.0 ** (20.1, 34.9) |
13.7 ** (8.9, 19.8) |
95.1 (83.5, 99.4) |
|
| EUROLINE-RN-AT IgG | 75.0 (56.6, 88.5) |
87.5 (61.7, 98.4) |
62.5 (35.4, 84.8) |
47.4 (24.4, 71.1) |
28.4 (21.3, 36.4) |
14.3 (9.4, 20.5) |
95.1 (83.5, 99.4) |
|
| EUROLINE-RN-AT IgM | 78.1 (60.0, 90.7) |
93.8 (69.8, 99.8) |
62.5 (35.4, 84.8) |
26.3 (9.1, 51.2) |
22.3 (15.9, 29.9) |
14.3 (9.4, 20.5) |
90.2 (76.9, 97.3) |
|
| EUROLINE-RN-AT IgG/IgM e | 87.5 (71.0, 96.5) |
100.0 (79.4, 100.0) |
75.0 (47.6, 92.7) |
57.9 (33.5, 79.7) |
35.8 (28.1, 44.1) |
22.0 (16.0, 29.1) |
85.4 (70.8, 94.4) |
|
* p < 0.05, ** p < 0.01, *** p < 0.001 (McNemar’s chi-square with EUROLINE-RN-AT approach as reference for US WB approach). a Immunoblot used for second test with a positive or equivocal ELISA. b A positive test result was defined as a positive/equivocal first-tier ELISA and a positive second-tier immunoblot. c Negativity was defined as a negative result in either or both tiers. d Number of days from onset of erythema migrans to test. e Combined evaluation of IgG and IgM immunoblot assay. f Combined evaluation of the anti-Borrelia plus VlsE ELISA IgG and the anti-Borrelia ELISA IgM.