Table 5.
Performance of Conventional and Alternative 2-Tiered Testing Algorithms Using European or US Serodiagnostic Assays
| No. Positive (%) |
||||||
|---|---|---|---|---|---|---|
| Conventional 2-Tier Using European Testsa | Conventional 2-Tier Using US Testsb | C6 ELISA Followed by US Immunoblotsc | US Tests and Hybrid IgG + VlsE Criteriad | US 2-EIA Algorithm (WCS + C6)e | C6 Peptide ELISA Alone | |
| Patients with Lyme borreliosis acquired in Europe (n = 64) | 52 (81) | 33 (52) [.0007] | 34 (53) [.001] | 47 (73) [.40] | 54 (84) [.82] | 56 (88) [.47] |
| Erythema migrans (n = 20) | 11 (55) | 4 (20) [.05] | 4 (20) [.05] | 11 (55) [1.00] | 13 (65) [.75] | 14 (70) [.51] |
| Lyme neuroborreliosis (n = 15) | 13 (87) | 6 (40) [.02] | 6 (40) [.02] | 13 (87) [1.00] | 13 (87) [1.00] | 13 (87) [1.00] |
| Lyme arthritis (n = 15) | 14 (93) | 9 (60) [.08] | 10 (67) [.17] | 9 (60) [.08] | 14 (93) [1.00] | 15 (100) [1.00] |
| Acrodermatitis chronica atrophicans (n = 14) | 14 (100) | 14 (100) [1.00] | 14 (100) [1.00] | 14 (100) [1.00] | 14 (100) [1.00] | 14 (100) [1.00] |
| Healthy control subjects from nonendemic area (n = 100) | 1 (1) | 0 (0) [1.00] | 0 (0) [1.00] | 0 (0) [1.00] | 0 (0) [1.00] | 0 (0) [1.00] |
Bracketed numbers represent the P values for the comparison with results obtained by 2-tiered testing using tests designed for use in Europe.
Abbreviations: EIA, enzyme immunoassay; ELISA, enzyme-linked immunosorbent assay; IgG, immunoglobulin G; VlsE, Vmp-like sequence, expressed; WCS, whole-cell sonicate.
a The values represent the number of serum samples that were positive or equivocal by European WCS immunoglobulin M(IgM) or WCS/recombinant Vmp-like sequence (rVlsE) IgG ELISA and positive by either IgM or IgG European immunoblots, interpreted according to European “MiQ 12 plus VlsE” criteria (Table 2).
b The values represent the number of serum samples that were positive or equivocal by US WCS polyvalent (IgM/IgG) ELISA and positive by either IgM or IgG US immunoblots, interpreted according to standard Centers for Disease Control and Prevention (CDC) criteria (Table 2). IgM criteria were not used if the duration of symptoms was >1 month at the time of specimen collection.
c The values represent the number of serum samples that were positive or equivocal by the US C6 peptide ELISA and positive by either IgM or IgG US immunoblots, interpreted according to standard CDC criteria. IgM criteria were not used if the duration of symptoms was >1 month at the time of specimen collection.
d For patients with erythema migrans or Lyme neuroborreliosis, and the control subjects, the values in this column represent the number of serum samples that were positive or equivocal by US WCS polyvalent ELISA and positive for the rVlsE band on US IgG immunoblots. For patients with Lyme arthritis or acrodermatitis chronica atrophicans, the values represent the number of serum samples that were positive or equivocal by US WCS polyvalent ELISA and that produced ≥5 of 11 specific IgG bands on US IgG immunoblots (10 bands described in standard CDC criteria, plus the rVlsE band).
e The values represent the number of serum samples that were positive or equivocal by US WCS polyvalent ELISA and positive or equivocal by US C6 peptide ELISA.