Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA: an international inter-laboratory assessment

BMC Infectious Diseases

Table 2 Accurate reproducibility of the Kalon HSV-2 IgG ELISA (N = 183; HSV-2 prevalence = 72 %) ^a

Kalon conditions	Sensitivity, % (95 % CI)	Specificity, % (95 % CI)	AUC (95 % CI)
IND as NEG ^b
Technologist-Jr.	90.1 (83.6–94.6)	100.0 (92.7–100.0)	0.95 (0.93–0.98)
Technologist-Sr. ^e	92.4 (86.4–96.3)	95.9 (86.0–99.5)	0.94 (0.91–0.98)
Technologist-Sr. ^f	94.7 (89.3–97.8)	98.0 (89.1–99.9)	0.96 (0.94–0.99)
Technologist-SA	88.5 (81.8–93.4)	100.0 (92.7–100.0)	0.94 (0.92–0.97)
Technologist-ZM	93.1 (87.4–96.8)	98.0 (89.1–99.9)	0.96 (0.93–0.98)
IND as POS ^c
Technologist-Jr.	93.1 (87.4–96.8)	98.0 (89.1–99.9)	0.96 (0.93–0.99)
Technologist-Sr. ^e	94.7 (89.3–97.8)	95.9 (86.0–99.5)	0.95 (0.91–0.99)
Technologist-Sr. ^f	96.2 (91.3–98.7)	98.0 (89.1–99.9)	0.97 (0.95–1.00)
Technologist-SA	91.6 (85.5–95.7)	95.9 (86.0–99.5)	0.94 (0.90–0.97)
Technologist-ZM	94.7 (89.3–97.8)	98.0 (89.1–99.9)	0.96 (0.94–0.99)
IND excluded ^d
Technologist-Jr.	92.9 (87.0–96.7)	100.0 (92.6–100.0)	0.97 (0.94–0.99)
Technologist-Sr. ^e	94.5 (89.1–97.8)	95.9 (86.0–99.5)	0.95 (0.92–0.99)
Technologist-Sr. ^f	96.1 (91.2–98.7)	98.0 (89.1–99.1)	0.97 (0.94–1.00)
Technologist-SA	91.3 (85.0–95.6)	100.0 (92.5–100.0)	0.96 (0.93–0.98)
Technologist-ZM	94.6 (89.1–97.8)	98.0 (89.1–99.9)	0.96 (0.94–0.99)

Abbreviations: POS positive, NEG negative, IND indeterminate, CI confidence interval, AUC area under the receiver operating characteristic curve
^aGold standard: UW-WB; indeterminate results by UW-WB were excluded in the analysis (n = 3)
^bIndeterminate results by Kalon were considered as negative in the analysis
^cIndeterminate results by Kalon were considered as positive in the analysis
^dIndeterminate results by Kalon were excluded in the analysis
^eKalon was performed at the HPTN Laboratory Center (USA site)
^fKalon was performed in the South African laboratory

ISSN: 1471-2334