Test Results - BÜHLMANN Quantum Blue Manuel D'utilisation

APPENDIX I
TABLES AND FIGURES / TABELLEN UND ABBILDUNGEN / TABLES ET FIGURES /TABELLE E FIGURE /
TABLAS Y FIGURAS/ TABELAS E FIGURAS

Test results

Figure 1A Figure 1B
Clinical study – distinguishing organic disease from
functional gastrointestinal disease
Distribution of patients' results in numbers (percent)
Final
within BÜHLMANN fCAL® ELISA diagnostic ranges.
diagnosis
< 80 µg/g 80 - 160 µg/g
IBD 9 (6.7%) 12 (8.9%)
IBS 94 (72.3%) 17 (13.1%)
Other GI 48 (66.7%) 10 (13.9%)
IBD vs. non-IBD
Sensitivity (95% CI) 93.3% (87.7%, 96.9%)
Specificity (95% CI) 70.3% (63.5%, 76.5%)
PPV (95% CI) 67.7% (60.5%, 74.4%)
NPV (95% CI) 94.0% (89.0%, 97.2%)
ROC AUC (95% CI)
IBD vs. IBS
Sensitivity (95% CI) 93.3% (87.7%, 96.9%)
Specificity (95% CI)
72.3% (63.8%, 79.8%)
PPV (95% CI) 77.8% (70.6%, 83.9%)
NPV (95% CI)
91.3% (84.1%, 95.9%)
ROC AUC (95% CI)
IBD vs. non-IBD
Sensitivity (95% CI) 96.3% (91.6%, 98.8%)
Specificity (95% CI)
59.9% (52.8%, 66.7%)
PPV (95% CI) 61.6% (54.7%, 68.2%)
NPV (95% CI)
96.0% (91.0%, 98.7%)
Release date: 2020-10-30
Figure 1C Figure 1D
> 160 µg/g
114 (84.4%) 135 (100%)
19 (14.6%) 130 (100%)
14 (19.4%) 72 (100%)
Clinical decision point
80 µg/g 160 µg/g
84.4% (77.2%, 90.1%)
83.7% (77.8%, 88.5%)
77.6% (69.9%, 84.0%)
88.9% (83.6%, 93.0%)
0.923 (0.893, 0.953)
Clinical decision point
80 µg/g 160 µg/g
84.4% (77.2%, 90.1%)
85.4% (78.1%, 91.0%)
85.7% (78.6%, 91.2%)
84.1% (76.7%, 89.9%)
0.933 (0.902, 0.963)
Clinical decision point
50 µg/g 200 µg/g
80.7% (73.1%, 87.0%)
87.1% (81.7%, 91.4%)
80.7% (73.1%, 87.0%)
87.1% (81.7%, 91.4%)
IBD vs. IBS
Readout
Sensitivity (95% CI)
window
Specificity (95% CI)
PPV (95% CI)
NPV (95% CI)
Sample
loading
port
Non-IBD – IBS + other GI
CI – confidence interval
PPV – positive predictive value
NPV – negative predictive value
Figure 1
ROC AUC – area under receiver operating characteristic curve
Precision profile
35 35
Total
30 30
25 25
Table 4
20 20
15 15
0 0 50 50
Linearity plot
450
Table 5
400
350
300
250
200
150
Table 6
100
50
0
0 0.1
Table 7
33/36
Clinical decision point
50 µg/g
96.3% (91.6%, 98.8%)
59.2% (50.3% ,67.8%)
71.0% (63.9%, 77.5%)
93.9% (86.3%, 98.0%)
100 100 150 150 200 200 250 250
Calprotectin [µg/g] Calprotectin [µg/g]
2
R = 0.994
Linear fit
(17.06 +387.2x)
Polynomial fit
(-0.9216 +515.3x -118.8x²)
0.2 0.3 0.4 0.5 0.6 0.7
Dilution Factor (1 = undiluted)
200 µg/g
80.7% (73.1%, 87.0%)
90.0% (83.5%, 94.6%)
89.3% (82.5%, 94.2%)
81.8% (74.5%, 87.8%)
Table 8
300 300 350 350 400 400
Figure 2
0.8 0.9 1
Figure 3
Quantum Blue® fCAL