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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%
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BMC Gastroenterology

ISSN: 1471-230X

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