Table 2.
Diagnostic assays evaluated in community screening survey, July 2009.
| Assay | Full Test Name (Manufacturer) | Ig Class | Antigen | Interpretation |
|---|---|---|---|---|
| ELISA | ||||
| C6 ELISA | C6 Bb Lyme ELISA (Immunetics, Boston, MA, USA) | IgG, IgM | Synthetic C6 peptide (25 aa) derived from IR6 of VlsE Bb (strain B31) | Index: ≤0.90 negative, 0.91–1.09 equivocal, ≥1.10 positive. |
| Anti-Borrelia plus VlsE ELISA IgG | Anti-Borrelia plus VlsE ELISA IgG (Euroimmun, Lübeck, Germany) | IgG | Mix of whole-cell antigen extracts from Bb, Ba and Bg plus VlsE Bb * | RU/mL: <16 negative, ≥16 to <22 equivocal, ≥22 positive. |
| Anti-VlsE ELISA IgG | Anti-Bb VlsE ELISA IgG (Euroimmun) | IgG | VlsE Bb * | RU/mL: <16 negative, ≥16 to <22 equivocal, ≥22 positive. |
| Anti-Borrelia ELISA IgM | Anti-Borrelia ELISA IgM (Euroimmun) | IgM | Mix of whole-cell antigen extracts from Bb, Ba and Bg | RU/mL: <16 negative, ≥16 to <22 equivocal, ≥22 positive. |
| Immunoblot | ||||
| WB IgG ** | US Anti-Bb EUROLINE-WB IgG (Euroimmun) | IgG | Whole-cell antigen extract from Bb | Positive if ≥5 of the following 10 bands were present: 18/21 kDa, OspC, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa (Fla), 45 kDa, 58 kDa, 66 kDa, 93 kDa; according to Dearborn criteria [6]. |
| VlsE IgG ** | IgG | VlsE Bb * | Only the VlsE band was scored. Positive if the VlsE band was present. | |
| WB IgM | US Anti-Bb EUROLINE-WB IgM (Euroimmun) | IgM | Whole-cell antigen extract from Bb plus p41 * | Positive if ≥2 of the following 3 bands were present: OspC, 39 kDa (BmpA), 41 kDa (Fla); according to Dearborn criteria [6]. |
| EUROLINE-RN-AT IgG | Anti-Borrelia EUROLINE-RN-AT IgG (Euroimmun) | IgG | p18 *, p19 *, p20 *, p21 *, p58 *, OspC *, p39 *, p41 *, p83 *, Lipid Bb, Lipid Ba, VlsE Bg *, VlsE Bb *, VlsE Ba * | Positive if ≥2 of the following 10 bands were present: p18, p19, p20, p21, p58, OspC, p39, p83, Lipid Bb, and Lipid Ba; or if ≥1 VlsE band was present even if no other specific bands were positive; according to European MiQ 12 criteria [7]. |
| EUROLINE-RN-AT IgM | Anti-Borrelia EUROLINE-RN-AT IgM (Euroimmun) | IgM | OspC Bg, OspC Bb, OspC Ba, p39 *, p41 *, VlsE Bb * | Positive if ≥1 of the following 5 bands was present: OspC Bg, OspC Bb, OspC Ba, p39, VlsE Bb; according to European MiQ 12 criteria [7]. |
* Purified recombinant protein. ** WB IgG test strips were each fitted with a membrane chip coated with recombinant VlsE antigen (Figure 1). Because reactivity against VlsE is not included in the Dearborn criteria, the VlsE band was evaluated separately (VlsE IgG). aa, amino acids; Bb, Borrelia burgdorferi sensu stricto; Ba, Borrelia afzelii; Bg, Borrelia garinii; BmpA, Borrelia membrane protein A; ELISA, enzyme-linked immunosorbent assay; Fla, Flagellin; IgG, immunoglobulin G; IgM, immunoglobulin M; IR6, sixth invariable region of VlsE; OspC, outer surface protein C; VlsE, variable major protein-like sequence, expressed; WB, Western blot.