Table 1.
Food and Drug Administration–Approved Treponemal-specific Tests
| Assay (Manufacturer) | Assay Type | Antigens | Antibodies | Sample Types |
|---|---|---|---|---|
| Immunoassays | ||||
| ADVIA Centaur (Siemens) | CIA | Recombinant TpN15, TpN17 | Not specified | Serum, heparinized plasma, EDTA plasma, citrate plasma |
| Architect Syphilis TP (Abbott) | CMIA | Recombinant TpN15, TpN17, TpN47 | IgG, IgM | Serum, plasma |
| AtheNA Multi-Lyte T. pallidum IgG Plus Test System (Zeus Scientific) | MFIA | Recombinant TpN17 | IgG | Serum |
| Bioplex 2200 Syphilis IgG (Biorad) | MFIA | Recombinant TpN15, TpN17, TpN47 | IgG | Serum |
| Bioplex 2200 Syphilis Total and RPR (Biorad) | MFIA | Recombinant TPN17, TPN47 | IgG, IgM | Serum, heparinized plasma, EDTA plasma |
| Captia Syphilis-G Assay (Trinity Biotech) | EIA | Wild-type antigens | IgG | Serum |
| Elecsys Syphilis (Roche) | CIA | Recombinant TpN15, TpN17, TpN47 | IgG, IgM | Serum, heparinized plasma, EDTA plasma, citrate plasma |
| Enzy-Well Syphilis IgG (Diesse Diagnostica Senese) | ELISA | Recombinant antigens (proprietary) | IgG | Serum, plasma |
| Immulite 2000 Syphilis Screen (Siemens) | CIA | Recombinant TpN17 | Not specified | Serum, heparinized plasma |
| LIAISON (Diasorin) | CIA | Recombinant TpN17 | IgG, IgM | Serum |
| Lumipulse G TP-N (Fujirebio) | CIA | Recombinant TpN15, TpN17, TpN47 | IgG, IgM | Serum, EDTA plasma, citrate plasma |
| Trep-Sure (Trinity Biotech) | EIA | Recombinant antigens (proprietary) | IgG, IgM | Serum, plasma |
| Zeus Scientific T Pallidum IgG Test System (Zeus Scientific) | ELISA | Recombinant TpN17 | IgG | Serum |
| Manual assays | ||||
| FTA-ABS | Indirect fluorescence | Wild-type, fixed to slide | IgG, IgM | Serum |
| MHA-TP | Agglutination | Wild-type, bound to sheep erythrocytes | IgG, IgM | Serum, plasma |
| TP-PA (Fujireibo) | Agglutination | Wild-type, bound to gelatin particles | IgG, IgM | Serum, plasma |
Abbreviations: CIA, chemiluminescence immunoassay; CMIA, chemiluminescent microparticle immunoassay; EDTA, ethylenediaminetetraacetic acid; EIA, enzyme immunoassay; ELISA, enzyme-linked immunosorbent assay; FTA-ABS, fluorescent treponemal antibody absorbed test; Ig, immunoglobulin; MFIA, multiplex flow immunoassay; MHA-TP, microhemagluttination assay for T. pallidum antibodies; TP-PA, Treponema pallidum particle agglutination assay.