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Poynard, T. et al.

Thierry Poynard, Mona Munteanu, Olivier Deckmyn, Yen Ngo, Fabienne Drane, Djamila Messous, Jean Marie Castille, Chantal Housset, Vlad Ratziu, Françoise Imbert-Bismut,

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. 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%.[1]

References

Applicability and precautions of use of liver injury biomarker FibroTest. A reappraisal at 7 years of age. Poynard, T., Munteanu, M., Deckmyn, O., Ngo, Y., Drane, F., Messous, D., Castille, J.M., Housset, C., Ratziu, V., Imbert-Bismut, F. BMC. Gastroenterol (2011) [Pubmed]

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