Table 5.

Cut-off values, sensitivity and specificity of the index InBios ELISA tests using the primary (fecal test) and secondary (CRS) reference standards

Reference standard	Indeterminate cases	Test	Cut-off value	Sensitivity (95% CI)	Pa	Specificity (95% CI)	Pa
Primary—fecal test	n/a	IgG	0.714	0.93 (0.88–0.97)	< 0.0001	0.91 (0.88–0.95)	0.0325
Primary—fecal test	n/a	IgG4	0.609	0.81 (0.74–0.87)		0.94 (0.91–0.97)
Secondary—CRS	Excluded	IgG	0.675	0.78 (0.72–0.83)	0.0011	0.98 (0.96–1.00)	0.6547
Secondary—CRS	Excluded	IgG4	0.32	0.70 (0.64–0.76)		0.97 (0.95–1.00)
Secondary—CRS	Included as negative cases	IgG	0.885	0.76 (0.71–0.82)	0.5316	0.98 (0.96–1.00)	0.0004
Secondary—CRS	Included as negative cases	IgG4	0.064	0.75 (0.69–0.81)		0.91 (0.88–0.95)
Secondary—CRS	Included as positive cases	IgG	0.675	0.54 (0.48–0.59)	0.0082	0.98 (0.96–1.00)	0.6547
Secondary—CRS	Included as positive cases	IgG4	0.32	0.49 (0.43–0.54)		0.97 (0.95–1.00)

CI, Confidence interval; CRS, composite reference standard, n/a, not available

^aP-values comparing sensitivities and specificities were determined by McNemar’s test