Improved Performance of ELISA and Immunochromatographic Tests Using a New Chimeric A2-Based Protein for Human Visceral Leishmaniasis Diagnosis

Table 5

Sensitivity, specificity, accuracy, and agreement of the VL-ICT versus the VL-ELISA using human samples from L. infantum-infected patients and healthy donors and VL/AIDS+), from panels 1 and 2.

VL () and healthy donors () (panel 1)
Assay type	ELISA (+)	ELISA (-)
ICT (+)	80	02
ICT (-)	07	83
(95% CI: 90.21–99.65%)	(95% CI: 84.12–96.70%)	(95% CI: 91.76–99.71%)
VL () and healthy donors () (panel 2)
Assay type	ELISA (+)	ELISA (-)
ICT (+)	145	4
ICT (-)	9	104
Total	154	108
(95% CI: 91.62–97.15%)	(95% CI: 86.65–95.39%)	(95% CI: 96.30–100.00%)
VL/AIDS+ () and healthy donors (4) (panel 2)
Assay type	ELISA (+)	ELISA (-)
ICT (+)	34	6
ICT (-)	12	58
Total	46	64
(IC 95%: 75.52–89.48%)	(IC 95%: 59.74–84.40%)	(IC 95%: 81.02–95.63%)
Concordance	Kappa index- (95% CI)	Value
ELISA versus ICT (VL)	0.898 (0.844–0.952)	0.2673
ELISA versus ICT (VL/AIDS+)	0.657 (0.514–0.801)	0.2386

VL: visceral leishmaniasis; ELISA: enzyme-linked immunosorbent assay; ICT: immunochromatographic test; All the 46 VL/AIDS+ samples were positive by VL-ELISA. McNemar test was used to estimate the statistical differences between ELISA and ICT. The differences were considered statistically significant when value .