TABLE 1.
Serum panels, clinical and laboratory definitions, and assay development stagea
| Provider (sample source and characteristics) | Clinical and laboratory definitions | No. of samples | EIA screening for 12 B. burgdorferi antigens | Comparative analysis of 3Ag-EIA vs 3Ag-mChip-Ld |
|---|---|---|---|---|
| NYSDOH (patients with suspected early Lyme disease, 2-tiered serology positive) | C6 and IgM/IgG blotting positive (acute phase, tick exposure, EM for <30 days) | 20 | X | |
| C6 and IgG blotting positive (convalescent phase, clinical signs for >30 days) | 39 | X | ||
| BR (healthy controls from areas of nonendemicity) | Healthy controls from areas of nonendemicity | 20 | X | |
| LDB (patients with lab-confirmed early Lyme disease and healthy controls from areas of endemicity) | Patients with 85% EM and positive by 2-tiered serology, 2-EIA, culture, or PCR | 20 | X | X |
| Healthy controls from areas of endemicity | 20 | X | ||
| NIH | ||||
| Patients with confirmed late Lyme disease | Patients with Lyme arthritis | 20 | X | X |
| Patients with PTLDS | Patients with PTLDS | 20 | X | |
| CDC (patients with confirmed early and late Lyme disease and negative controls) | Patients with early Lyme disease (EM, acute and convalescent phases) | 33 | X | |
| Patients with early disseminated disease with neurologic disease/carditis and Lyme arthritis | 8 | X | ||
| Healthy controls (from areas of endemicity and nonendemicity) and patients with look-alike diseases | 41 | X |
Abbreviations: C6, Immunetics C6 EIA; mChip-Ld, microfluidic rapid assay; EM, erythema migrans. A total of 241 serum samples were tested. For the discovery/screening phase, we used serum from patients with early and late Lyme disease, confirmed Lyme disease (LDB and NIH panels), and suspected Lyme disease with a positive 2-tiered serology (NYSDOH panel). For the comparative analysis, we tested only panels of serum samples from patients with confirmed Lyme disease that are commonly used (early and late Lyme disease, but not PTLDS); the CDC panel was not used for screening, given that panels for which the investigators are blind to the results are unsuitable for use in the discovery phase.