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




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* Corresponding author 1 Service d-Hépato-Gastroentérologie CHU Pitié-Salpêtrière 2 Biopredictive

Abstract : 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%.





Author: Thierry Poynard - Mona Munteanu - Olivier Deckmyn - Yen Ngo - Fabienne Drane - Djamila Messous - Jean Castille - Chantal Housset

Source: https://hal.archives-ouvertes.fr/



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