A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease

Halfon, Philippe; Imbert‐Bismut, Françoise; Messous, Djamila; Antoniotti, G.; Benchetrit, Didier; Cart-Lamy, Philippe; Delaporte, Gilles; Doutheau, Danièle; Klump, Théo; Sala, Michel; Thibaud, Didier; Trépo, Elisabeth; Thabut, Dominique; Myers, Robert P.; Poynard, Thierry

doi:10.1186/1476-5926-1-3

Cited by 96 publications

(14 citation statements)

References 12 publications

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“…The validation study would be necessary to confirm the stability for these cut-offs, although it will not be feasible to obtain the dataset for validation. In addition, other reported laboratory liver fibrosis indices, including FibroIndex [ 22 ], Fibrometer [ 23 ], FibroTest [ 24 ], and Hepascore [ 25 ], were not evaluated due to the lack of laboratory data needed to calculate these indices. Evaluation of these markers in patients with SVR is necessary for determining the best laboratory markers for estimating the degree of liver fibrosis in patients after HCV eradication in the future.…”

Section: Discussionmentioning

confidence: 99%

Predictive Ability of Laboratory Indices for Liver Fibrosis in Patients with Chronic Hepatitis C after the Eradication of Hepatitis C Virus

et al. 2015

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Liver fibrosis remains an important risk factor for hepatocarcinogenesis in patients with chronic hepatitis C even after the eradication of hepatitis C virus (HCV). However, it is difficult to estimate liver fibrosis based on liver biopsy after the eradication of HCV. We investigated the ability of laboratory indices to predict liver fibrosis in patients with sustained virologic response (SVR) to antiviral therapy. Three laboratory liver fibrosis indices (aspartate aminotransferase-platelet ratio index (APRI), FIB-4 index, and Forns index) were calculated based on data at the time of initial pretreatment liver biopsy and at second liver biopsy performed approximately 5 years after SVR in 115 patients who underwent serial liver biopsies. The indices at the time of initial biopsy were compared to histological degree of liver fibrosis in initial biopsy, and laboratory indices at the time of second liver biopsy were compared to the degree of fibrosis in second biopsy. In both comparisons, there were significant increases in all 3 indices with the increase of liver fibrosis grade as assessed in liver biopsy specimens. All 3 indices at the time of second biopsy were able to predict moderate to advanced (METAVIR score F2-4) and advanced (F3-4) fibrosis on liver biopsy, with the area under the receiver-operating characteristics curve >0.8 and the accuracy >70%. All 3 laboratory indices of fibrosis accurately reflected liver fibrosis in patients with SVR for 5 years despite the normalization of serum liver transaminase activity and the lack of liver inflammation.

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Section: Discussionmentioning

confidence: 99%

Predictive Ability of Laboratory Indices for Liver Fibrosis in Patients with Chronic Hepatitis C after the Eradication of Hepatitis C Virus

et al. 2015

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“…Dozens of serum liver fibrosis models have been developed and validated in clinical practice, all of them noninvasive, low-cost, and with AUROCs 0.50 ~ 0.86 ( 10 ). However, some serum models include biomarkers that are not routinely available, such as haptoglobin in Fibrotest ( 22 ) and α2-macroglobulin in Fibroscore ( 23 ), which is why many hospitals do not perform them. Furthermore, these models entail greater financial cost.…”

Section: Discussionmentioning

confidence: 99%

Performance of several simple, noninvasive models for assessing significant liver fibrosis in patients with chronic hepatitis B

Zeng

et al. 2015

Croat Med J

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AimTo compare the performance of several simple, noninvasive models comprising various serum markers in diagnosing significant liver fibrosis in the same sample of patients with chronic hepatitis B (CHB) with the same judgment standard.MethodsA total of 308 patients with CHB who had undergone liver biopsy, laboratory tests, and liver stiffness measurement (LSM) at the Southwest Hospital, Chongqing, China between March 2010 and April 2014 were retrospectively studied. Receiver operating characteristic (ROC) curves and area under ROC curves (AUROCs) were used to analyze the results of the models, which incorporated age-platelet (PLT) index (API model), aspartate transaminase (AST) to alanine aminotransferase (ALT) ratio (AAR model), AST to PLT ratio index (APRI model), γ-glutamyl transpeptidase (GGT) to PLT ratio index (GPRI model), GGT-PLT-albumin index (S index model), age-AST-PLT-ALT index (FIB-4 model), and age-AST-PLT-ALT-international normalized ratio index (Fibro-Q model).ResultsThe AUROCs of the S index, GPRI, FIB-4, APRI, API, Fibro-Q, AAR, and LSM for predicting significant liver fibrosis were 0.726 (P < 0.001), 0.726 (P < 0.001), 0.621 (P = 0.001), 0.619 (P = 0.001), 0.580 (P = 0.033), 0.569 (P = 0.066), 0.495 (P = 0.886), and 0.757 (P < 0.001), respectively. The S index and GPRI had the highest correlation with histopathological scores (r = 0.373, P < 0.001; r = 0.372, P < 0.001, respectively) and LSM values (r = 0.516, P < 0.001; r = 0.513, P < 0.001, respectively). When LSM was combined with S index and GPRI, the AUROCs were 0.753 (P < 0.001) and 0.746 (P < 0.001), respectively.ConclusionS index and GPRI had the best diagnostic performance for significant liver fibrosis and were robust predictors of significant liver fibrosis in patients with CHB for whom transient elastography was unavailable.

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“…To be validated and interpretable, the components assays of FT must follow the pre-analytical and analytical recommendations: measurements are calibrated and performed according to standardized reagents against reference materials; expression in multiples of the upper limit of reference values should not be employed [10-15]; and company-approved analyzers and kits are used to generate quantified values of the individual markers [4]. Since the first study, 157 peer-reviewed publications including several meta-analyses, have consistently validated the accuracy of FT-AT for assessing the stages of liver fibrosis when these technical recommendations have been utilized and when the area under the receiver operating characteristics curve has been standardized according to stage spectrum.…”

Section: Methodsmentioning

confidence: 99%

“…Due to these limitations of the classical definition of false positive/false negative, we propose to use the concept of "high risk profile of false positive/false negative results" (RFPN) and to use it for the definition of FT applicability for the identification of deviance from recommended pre-analytical and analytical procedures [10-15]. …”

Section: Introductionmentioning

confidence: 99%

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

et al. 2011

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BackgroundFibroTest (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.MethodsFour 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.ResultsThe 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.ConclusionThe 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%.

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A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease

Cited by 96 publications

References 12 publications

Predictive Ability of Laboratory Indices for Liver Fibrosis in Patients with Chronic Hepatitis C after the Eradication of Hepatitis C Virus

Predictive Ability of Laboratory Indices for Liver Fibrosis in Patients with Chronic Hepatitis C after the Eradication of Hepatitis C Virus

Performance of several simple, noninvasive models for assessing significant liver fibrosis in patients with chronic hepatitis B

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

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