Skip to main content

Table 1 Characteristics of included populations

From: Applicability and precautions of use of liver injury biomarker FibroTest. A reappraisal at 7 years of age

Name of Population P1 Blood donors P2 Healthy volunteers P3 Worldwide patients P4 Reference Center
patients
Consecutive cases (n) 1,037 7,554 361,096 24,872
Included cases (n) n = 954 n = 7,494 n = 345,695 n = 24,872
Age mean year (SD; range) 35.75 (12.24;18-67) 56.97 (6.77; 40-90) 49.73 (13.87; 0-101) 49.36 (13.60;0-101)
Gender     
Male 483 (50.63%) 4138 (55.22%) 198612 (57%) 15530 (62.44%)
Female 471 (49.37%) 3356 (44.78%) 147083 (43%) 9342 (37.56%)
Country of residency/ancestry Residency Ancestry Residency Residency
Western Europe 1037 (100%) 6705 (89.47%) 295685 (85.53% 24,872 (100%)
Middle East 0 (0%) 0 (0%) 28001 (8.10%) 0 (0%)
Eastern Europe 0 (0%) 0 (0%) 5209 (1.51%) 0 (0%)
North Africa 0 (0%) 467 (6.23%) 6464 (1.87% 0 (0%)
North America 0 (0%) 0% (0%) 7726 (2.23% 0 (0%)
Central America 0 (0%) 0% (0%) 1436 (0.42%) 0 (0%)
Far East 0 (0%) 92 (1.23%) 993 (0.29%) 0 (0%)
South America 0 (0%) 0% (0%) 181 (0.05%) 0 (0%)
Sub-Saharan Africa 0 (0%) 230 (3.07%) 0 (0%) 0 (0%)
Laboratory experience     
> 10,000 tests (n = 6) 954 (100%) 7494 (100%) 143772 (41.49%) 24,872 (100%)
< 10,000 tests (n = 443) 0 (0%) 0 (0%) 201923 (58.41%) 0 (0%)
HIV positive patients     
Yes 0 (0%) 2 (0.003%) 2602 (0.75%)3 NA
Negative 954 (100%) 1012/1014 (13.50%) 0 (0%) NA
Unknown 0 (0%) 6443 (66.50%) 343093 (99.25%) NA
Liver Disease Risk    Unknown Only known for high risk profile
Non Alcoholic Fatty Liver 105 (11.01%) 2930 (39.29%) NA NA
Alcoholic Liver Disease 82 (8.59%) 883 (11.84%) NA NA
NAFLD/ALD 19 (1.99%) 1036 (13.89%) NA NA
Hepatitis C Virus 0 (0%) 31 (0.42%) NA NA
Hepatitis B Virus 0 (0%) 3 (0.04%) NA NA
Other 0 (0%) 2 (0.03%) NA NA
No Risk 748 (78.41%) 2572 (34.49%) NA NA
FibroTest     
FibroTest mean (SD; 1%-99% percentiles) 0.11 (0.08;0.01-0.41) 0.17 (0.12;0.03-0.60) 0.42 (0.27;0.03-0.97) 0.40 (0.28;0.03-0.98)
F0 or F0-F1 908 (95.18%) 6302 (84.09)% 131658 (38.09%) 10526 (42.32%)
F1 or F1-F2 42 (4.40%) 927 (12.37)% 77974 (22.56%) 5302 (21.32%)
F2 0 (0%) 151 (2.01%)2 31646 (9.15%) 2059 (8.28%)
F3 or F3-F4 3 (0.31%)1 76 (1.01%)2 46021(13.31%) 2979 (11.98%)
F4 1 (0.10%)1 38 (0.51%)2 58396 (16.89%) 4006 (16.11%)
Actitest     
Actitest mean (SD; 1%-99% percentiles) 0.08 (0.07;0.01-0.40) 0.11 (0.10;0.02-0.52) 0.37 (0.26;0.02-0.95) 0.30 (0.24;0.02-0.93)
A0 or A0-A1 935 (98.01%) 7060 (94.52%) 166068 (48.05%) 14823 (59.72%)
A1 or A1-A2 16 (1.68%) 347 (4.46%) 84102 (24.33%) 5207 (20.98%)
A2 or A2-A3 1 (0.10%) 39 (0.48%) 26714 (7.73%) 1455 (5.86%)
A3 2 (0.21%) 48 (0.64%) 68741 (19.89%) 3334 (13.43%)
FibroTest-ActiTest     
Interpretable 949 (99.48%; 98.78-99.83) 7456 (99.49%; 99.30-99.64) 342,346 (99.03%; 99.00-99.06) 24381 (98.03%; 97.95-98.20)
High risk False Positive/Negative (95% CI) 5 (0.52%; 0.17-1.22) 38 (0.51%; 0.36-0.70) 3349 (0.97%; 0.94-1.00) 491 (1.97%; 1.80-2.15)
  1. 1 All four cases with Fibrotest greater than 0.48 had a high-risk profile of components which were detected by security algorithms (one low A2M and 3 low haptoglobin).
  2. 2 31 cases out of the 265 cases with FibroTest greater than 0.48 had a high-risk profile of components which were detected by security algorithms.
  3. NA = not available
  4. 3 Hospital unit with prevalence of HIV > 90%