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

BMC Gastroenterol. 2011 Apr 14;11:39. doi: 10.1186/1471-230X-11-39.

Abstract

Background: FibroTest (FT) is a validated biomarker of fibrosis. To assess the applicability rate and to reduce the risk of false positives/negatives (RFPN), security algorithms were developed. The aims were to estimate the prevalence of RFPN and of proven failures, and to identify factors associated with their occurrences.

Methods: Four populations were studied: 954 blood donors (P1), 7,494 healthy volunteers (P2), 345,695 consecutive worldwide sera (P3), including 24,872 sera analyzed in a tertiary care centre (GHPS) (P4). Analytical procedures of laboratories with RFPN > 5% and charts of P4 patients in with RFPN were reviewed.

Results: The prevalence of RFPN was 0.52% (5/954; 95%CI 0.17-1.22) in P1, 0.51% (38/7494; 0.36-0.70) in P2, and 0.97% (3349/345695; 0.94-1.00) in P3. Three a priori high-risk populations were confirmed: 1.97% in P4, 1.77% in HIV centre and 2.61% in Sub-Saharan origin subjects. RFPN was mostly associated with low haptoglobin (0.46%), and high apolipoproteinA1 (0.21%). A traceability study of a P3 laboratory with RFPFN > 5% permitted to correct analytical procedures.

Conclusion: The mean applicability rate of Fibrotest was 99.03%. Independent factors associated with the high risk of false positives/negatives were HIV center, subSaharan origin, and a tertiary care reference centre, although the applicability rate remained above 97%.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Algorithms
  • Apolipoprotein A-I / blood*
  • Bilirubin / blood*
  • Biomarkers / blood
  • Child
  • Child, Preschool
  • False Negative Reactions
  • False Positive Reactions
  • Female
  • Haptoglobins / metabolism*
  • Humans
  • Infant
  • Liver Cirrhosis / blood*
  • Liver Cirrhosis / diagnosis*
  • Male
  • Middle Aged
  • Software*
  • Young Adult
  • alpha-Macroglobulins / metabolism*
  • gamma-Glutamyltransferase / blood*

Substances

  • Apolipoprotein A-I
  • Biomarkers
  • Haptoglobins
  • alpha-Macroglobulins
  • gamma-Glutamyltransferase
  • Bilirubin