Table 1.

Assay performance characteristics of UCP-LFAs in MTB infected rhesus macaques.

(a). Assay performance to discriminate pre and postinfection (n = 75)
	Cut off	Sensitivity (%)	95% CI (%)	Specificity (%)	95% CI (%)	AUC-ROC	p Value
SAA1	R > 0.336	66.67	55.42 to 76.29	100	95.13 to 100.0	0.8241	<0.0001
IP-10	R > 0.766	61.33	50.02 to 71.54	93.33	85.32 to 97.12	0.8445	<0.0001
IL-6	R > 0.034	60	48.69 to 70.34	94.67	87.07 to 97.91	0.7907	<0.0001
3BM	#pos BM ≥ 1	78.67	68.12 to 86.42	89.33	80.34 to 94.50	0.8694	<0.0001
(b). Assay performance to discriminate pre and postinfection (n = 36)
	Cut off	Sensitivity (%)	95% CI (%)	Specificity (%)	95% CI (%)	AUC-ROC	p Value
SAA1	R > 0.350	75.00	58.93 to 86.25	100	90.36 to 100.00	0.8738	<0.0001
IP-10	R > 0.656	86.11	71.34 to 93.92	91.67	78.17 to 97.13	0.9502	<0.0001
IL-6	R > 0.055	63.89	47.58 to 77.52	97.22	85.83 to 99.86	0.8214	<0.0001
3BM	#pos BM ≥ 1	86.11	71.34 to 93.92	88.89	74.69 to 95.59	0.9150	<0.0001

SAA1, IP-10 and IL-6 levels were measured by UCP-LFAs in serum from MTB Erdman infected rhesus macaques (n = 75) before infection and at the study endpoint. Results are displayed as the Ratio value (R) between Test (T) and Flow-Control (FC) signal based on relative fluorescence units (RFUs; excitation at 980 nm and emission at 550 nm) measured at the respective lines on the UCP-LF strips. The ability to distinguish pre from postinfection states in the same animals was evaluated by ROC curve analysis, and the corresponding Area Under the Curve (AUC) was determined (ROC-AUC). The cut-off value for each biomarker was determined by Youden’s index; values above the cutoff for each biomarker were considered positive. A 3BM (3 biomarkers) signature was generated using the sum of all positive tests results from the individual markers. (a) Assay performance in MTB Erdman infected rhesus macaques (n = 75). (b) Assay performance in unvaccinated rhesus macaques only (n = 36), infected with a high- (500 CFU, n = 24) or a low-dose (15 CFU, n = 12) of MTB Erdman. CI, confidence interval.