Table 3.

Sensitivity and Specificity of Treponemal Immunoassays for Diagnosis of Syphilis in Clinically Characterized Specimens (Published Data)

	Test performance, % (95% CI)
Assay	Stage	Sensitivity	Specificity	References
ADVIA Centaur	Primary	(52/55), 94.5% (84.9–98.9)	(385/403), 95.5% (93.0–97.3)	Park [13]
	Secondary	(98/98), 100% (96.2–100)
	Early latent	(41/41), 100% (90.7–100)
	Late latent	(64/68), 94.1% (85.6–98.4)
	Overall	(255/262) 97.3% (94.6–98.9)
Architect Syphilis	Overall	97.3–100%	94.5–100%	Liu [22], Marangoni [26], Saral [27], Wellinghausen [25], Xia [28], Xu [29]
Bioplex 2200 Syphilis IgG	Primary	(53/55), 96.4% (94.5–98.2)	(390/403), 96.9% (94.1–98.7)	Park [13]
	Secondary	(98/98), 100% (96.2–100)
	Early latent	(39/41), 95.1% (83.8–99.4)
	Late latent	(64/68), 94.1% (85.6–98.4)
	Overall	(264/262), 96.9% (94.1–98.7)
Captia Syphilis-G Assay	Primary	82.3–100%	97.8–100%	Cole [21], Lefevre [30], Siletti [31], Young [17, 32, 33]
	Secondary	100%
	Early latent	100%
	Late latent	91.7–100%
	Overall	94.7–100%
Elecsys Syphilis	Overall	(57/57), 100% (93.9–100)	(519/527), 98.5% (97.0–99.3)	Xia [28]
LIAISON	Primary	96.4–100%	94.5–100%	Marangoni [34], Park [13], Wellinghausen [25]
	Secondary	100%
	Latent (combined)	96.1%
	Early latent	97.6%
	Late latent	92.6%
	Overall	94.5–100%
Trep-Sure	Primary	(52/55), 94.5% (84.9–98.9) [13]; (28/52), 53.8% (39.5–67.8) [35]	(333/403), 82.6% (78.4–86.1)	Park [13], Gratzer [35]
	Secondary	(98/98), 100% (96.2–100)
	Early latent	(41/41), 100% (90.7–100)
	Late latent	(67/68), 98.5% (92.1–99.9)
	Overall	(258/262), 98.5% (96.1–99.6)

If the study distinguished specimens by treatment status, data for untreated patients are presented. For tests with only 1 published reference, sample sizes, and CIs are listed; otherwise, ranges of sensitivity/specificity estimates are listed. For sensitivity n/N represents positive test/true positives. For specificity n/N represents negative test/true negatives.

Abbreviation: CI, confidence interval.