Table 4.
Sensitivity or Positive Percentage Agreement of Treponemal Tests for Diagnosis of Syphilis by Stage and Treatment Status [FDA Premarket 510(k) Data]
| Assay | Test Performance | Reference | |
|---|---|---|---|
| ADVIA Centaur | Patients with syphilis not analyzed separately | [40] | |
| Architect Syphilis TP | Untreated (no 95% CI) | Treated (no 95% CI) | [39] |
| Primary (25/25), 100% Secondary (27/27), 100% Latent (29/29) 100% | Primary (33/44), 75% Secondary (29/29), 100% Latent (25/25), 100% | ||
| AtheNA Multi-Lyte T. pallidum IgG | Untreated | Treated | [42] |
| Primary, N/A Secondary (40/43), 93.0% (80.8–98.5) Latent (6/11), 54.5% (23.4–83.3) | Primary (10/11), 90.9% (58.7–99.8) Secondary (39/39), 100% (92.6–100) Latent (45/52), 86.5% (74.2–94.4) | ||
| Congenital (2/3), 66.7% (9.4–99.2) | |||
| Bioplex 2200 Syphilis IgG | Untreated | Treated | [44] |
| Primary (10/12), 83.3% (55.2–100) Secondary (10/10), 100% (72.2–100) Latent (8/13), 61.5% (35.5–82.3) | Primary (15/16), 93.8% (71.6–98.9) Secondary (36/36), 100% (90.3–100) Latent (49/53), 92.5% (82.1–97.0) | ||
| Bioplex 2200 Syphilis Total | Untreated | Treated | [36] |
| Primary (25/26) 96.2% (81.1–99.3) Secondary (25/25) 100% (87.1–100) Latent (23/23) 100% (85.7–100) | Primary (25/29) 86.2%, (69.4–94.5) Secondary (26/26), 100% (87.1–100) Latent (27/27), 100% (85.1–100) | ||
| Captia Syphilis-G Assay | N/A, see Table 3 | ||
| Elecsys Syphilis | Untreated | Treated | [37] |
| Primary (25/25), 100% Secondary (25/25), 100% Latent (25/25), 100% | Primary (16/29) 55% Secondary (24/25), 96% Latent (25/25) 100% | ||
| Enzy-Well Syphilis IgG | N = 125 pediatric and adult patients with syphilis, who were reactitve w/Captia Syphilis G; positive % agreement, all stages combined: (125/125), 100% (no 95% CI provided) | [45] | |
| Immulite 2000 Syphilis Screen | N = 281 patients with “medically diagnosed” syphilis, n = 272 reactive with w/LIAISON; positive % agreement, all stages combined: 270/272, 99.3%, (97.4–99.9) | [43] | |
| LIAISON | N = 51 patients with “medically diagnosed syphilis,” n = 48 reactive with Captia Syphilis G; positive % agreement, all stages combined: 47/48, 97.9% (89.0–99.9) | [46] | |
| Lumipulse G TP-N | Untreated (no 95% CI) | Treated (no 95% CI) | [38] |
| Primary (27/27), 100% Secondary (30/30), 100% Latent (183/200), 91.5% | Primary (2/2), 100% Secondary (25/25), 100% Latent (5/5), 100% | ||
| Trep-Sure | N/A patients with syphilis not analyzed separately (see Table 3) | ||
| Zeus Scientific T Pallidum IgG Test System | Untreated | Treated | [41] |
| Primary, N/A Secondary (41/43), 95.3% (84.2–99.4) Latent (6/11), 54.5% (23.4–83.3) | Primary (11/11), 100% (76.2–100) Secondary (39/39), 100% (92.6–100) Latent (48/50), 96% (86.3–99.5) | ||
Abbreviations: CI, confidence interval; FDA, Food and Drug Administration; N/A, not applicable.