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

作者：Poynard Thierry^*; Munteanu Mona; Deckmyn Olivier; Yen Ngo; Drane Fabienne; Messous Djamila; Castille Jean Marie; Housset Chantal; Ratziu Vlad; Imbert Bismut Francoise

来源：BMC Gastroenterology, 2011, 11: 39.

DOI：10.1186/1471-230X-11-39

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%.

• 出版日期2011-4-14