1. Applicability and precautions of use of liver injury biomarker FibroTest. A reappraisal at 7 years of age.
- Author
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Poynard T, Munteanu M, Deckmyn O, Ngo Y, Drane F, Messous D, Castille JM, Housset C, Ratziu V, and Imbert-Bismut F
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Algorithms, Biomarkers blood, Child, Child, Preschool, False Negative Reactions, False Positive Reactions, Female, Humans, Infant, Male, Middle Aged, Young Adult, Apolipoprotein A-I blood, Bilirubin blood, Haptoglobins metabolism, Liver Cirrhosis blood, Liver Cirrhosis diagnosis, Software, alpha-Macroglobulins metabolism, gamma-Glutamyltransferase blood
- 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%. more...
- Published
- 2011
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