TABLE 1.
Biospecimen cohorts used in this studya
| Cohort | Source | No. of specimens | STTT result (%) |
|||
|---|---|---|---|---|---|---|
| Negative | IgG+b | IgG+, IgM+b | IgM+b | |||
| Lyme disease discovery cohort | MC | 222 | 0 (0) | 96 (43) | 13 (6) | 113 (51) |
| Lyme disease validation cohort | MC | 454 | 0 (0) | 97 (21) | 163 (36) | 194 (43) |
| Controls | ||||||
| Discovery cohort (tested)d | CDC | 39 | 36 (92) | 0 (0) | 0 (0) | 3 (8) |
| Discovery cohort (untested) | Commercial | 391 | NA | NA | NA | NA |
| Validation cohort (untested) | Commercial | 1,076 | NA | NA | NA | NA |
| Clinically defined Lymec | CDC | 71 | ||||
| Lyme arthritis, carditis, neuroborelliosis | 37 | 0 (0) | 20 (54) | 13 (35) | 4 (11) | |
| Acute | 34 | 20 (59) | 3 (9) | 4 (12) | 7 (21) | |
| Convalescent (matched) | 34 | 10 (29) | 5 (15) | 7 (21) | 12 (35) | |
| Clinically defined Lyme | LDB | 48 | ||||
| Early | 25 | 13 (52) | 1 (4) | 4 (17) | 7 (30) | |
| Acute | 23 | 13 (52) | 2 (9) | 0 (0) | 9 (39) | |
| Convalescent (matched) | 23 | 10 (43) | 1 (4) | 4 (17) | 8 (35) | |
| Clinically defined controls | CDC | 131 | ||||
| Endemic, nonendemicd | 53 | 53 (100) | 0 (0) | 0 (0) | 0 (0) | |
| Mononucleosisd | 21 | 18 (86) | 0 (0) | 0 (0) | 3 (14) | |
| Fibromyalgia | 16 | 16 (100) | 0 (0) | 0 (0) | 0 (0) | |
| Multiple sclerosis | 11 | 11 (100) | 0 (0) | 0 (0) | 0 (0) | |
| Rheumatoid arthritis | 10 | 10 (100) | 0 (0) | 0 (0) | 0 (0) | |
| Syphilis | 10 | 9 (90) | 0 (0) | 0 (0) | 1 (10) | |
| Periodontitis | 10 | 9 (90) | 0 (0) | 0 (0) | 1 (10) | |
| Clinically defined controls | LDB | 126 | 124 (98) | 1 (1) | 0 (0) | 1 (1) |
a
Abbreviations: CDC, Centers for Disease Control and Prevention; LDB, Lyme Disease Biobank; MC, Mayo Clinic; NA, not applicable.
b
IgG+, IgG positive; IgM+, IgM positive.
c
Forty-two clinically defined Lyme disease samples were included into Lyme panel discovery.
d
Nineteen endemic and nonendemic samples plus twenty mononucleosis control samples were included in the Lyme panel discovery.