title: Applicability and precautions of use of liver injury biomarker FibroTest. A reappraisal at 7 years of age.
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.
  
  
  CONCLUSIONS
  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%.
authors.affiliation: APHP UPMC Paris Liver Center, Paris, France. tpoynard@teaser.fr
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
authors.forename: Mona
authors.initials: M
authors.lastname: Munteanu
authors.forename: Olivier
authors.initials: O
authors.lastname: Deckmyn
authors.forename: Yen
authors.initials: Y
authors.lastname: Ngo
authors.forename: Fabienne
authors.initials: F
authors.lastname: Drane
authors.forename: Djamila
authors.initials: D
authors.lastname: Messous
authors.forename: Jean Marie
authors.initials: JM
authors.lastname: Castille
authors.forename: Chantal
authors.initials: C
authors.lastname: Housset
authors.forename: Vlad
authors.initials: V
authors.lastname: Ratziu
authors.forename: Françoise
authors.initials: F
authors.lastname: Imbert-Bismut
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D016632:Apolipoprotein A-I / Q000097:blood*; D001663:Bilirubin / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006242:Haptoglobins / Q000378:metabolism*; D006801:Humans; D007223:Infant; D008103:Liver Cirrhosis / Q000097:blood* / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D012984:Software; D055815:Young Adult; D000511:alpha-Macroglobulins / Q000378:metabolism*; D005723:gamma-Glutamyltransferase / Q000097:blood*
chemical_list: D016632:Apolipoprotein A-I; D015415:Biomarkers; D006242:Haptoglobins; D000511:alpha-Macroglobulins; D005723:gamma-Glutamyltransferase; D001663:Bilirubin