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      Noninvasive biomarkers FibroTest and ActiTest versus liver biopsy in chronic hepatitis C patients: the Middle East experience

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          Abstract

          Background

          The aim of this study was to compare noninvasive biomarkers, FibroTest and ActiTest in predicting fibrosis stage and inflammation grade in chronic hepatitis C (CHC) patients with liver biopsy (LB).

          Methods

          In 107 patients with CHC, levels of six serum biomarkers (alanine aminotransferase, γ-glutamyl transpeptidase, total bilirubin, haptoglobin, apolipoprotein, α-2 macroglobulin) were determined at the time of LB. LB was evaluated by Metavir score for fibrosis and inflammation. Voluntary blood donors (n=106) were taken as controls for the study.

          Results

          Fibrosis estimated by Fibrotest was significantly higher in patients compared to control group. The observed area under the receiver operating characteristic curve (AUROC) for advanced fibrosis (F3, F4) adjusted according to the observed difference between advanced and non-advanced fibrosis prevalence (DANA) was 0.80 (0.69-0.88) and the AUROC for cirrhosis (F4) was 0.94 (0.86-0.98). ActiTest AUROC for moderate to severe activity (A2A3) was 0.72 (0.61-0.81), and for severe activity (A3) was 0.88 (0.78-0.93). The diagnostic values in the group of good quality biopsy (n=41) showed Fibrotest AUROC (DANA-adjusted): for advanced fibrosis 0.90 (0.72-0.99); for cirrhosis 0.93 (0.76-0.98); and ctiTest AUROC: for moderate/severe activity 0.86 (0.67-0.94); and for severe activity 0.90 (0.76-0.93). There was good concordance between FibroTest and LB (with discordance for two or more stages in <20% for advanced fibrosis and <10% for cirrhosis) and between ActiTest and LB. Specificity for FibroTest and ActiTest in the control population were 95% and 100% respectively.

          Conclusions

          Fibrotest and ActiTest had high observed and standardized diagnostic values for predicting fibrosis and activity respectively.

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          Most cited references20

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          A novel panel of blood markers to assess the degree of liver fibrosis.

          The objective was to develop new blood tests to characterize different fibrosis parameters in viral and alcoholic chronic liver diseases. Measurements included 51 blood markers and Fibrotest, Fibrospect, ELFG, APRI, and Forns scores. The clinically significant fibrosis was evaluated via Metavir staging (F2-F4), and image analysis was used to determine the area of fibrosis. In an exploratory step in 383 patients with viral hepatitis, the area under the receiving operator characteristic (AUROC) curve for stages F2-F4 in a test termed the "Fibrometer" test combining platelets, prothrombin index, aspartate aminotransferase, alpha2-macroglobulin (A2M), hyaluronate, urea, and age was 0.883 compared with 0.808 for the Fibrotest (P = .01), 0.820 for the Forns test (P = .005), and 0.794 for the APRI test (P < 10(-4)). The Fibrometer AUROC curve was 0.892 in the validating step in 120 patients. The AUROC curve for stages F2-F4 in a test combining prothrombin index, A2M, hyaluronate, and age was 0.962 in 95 patients with alcoholic liver diseases. The area of fibrosis was estimated in viral hepatitis by testing for hyaluronate, gamma-glutamyltransferase, bilirubin, platelets, and apolipoprotein A1 ((a)R(2) = 0.645), and in alcoholic liver diseases by testing for hyaluronate, prothrombin index, A2M, and platelets ((a)R(2) = 0.836). In conclusion, the pathological staging and area of liver fibrosis can be estimated using different combinations of blood markers in viral and alcoholic liver diseases. Whereas the Fibrometer has a high diagnostic accuracy for clinically significant fibrosis, blood tests for the area of liver fibrosis provide a quantitative estimation of the amount of fibrosis, which is especially useful in cirrhosis.
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            Exceeding the limits of liver histology markers.

            Alternatives to liver biopsy for staging liver disease caused by hepatitis C virus (HCV) have not appeared accurate enough for widespread clinical use. We characterized the magnitude of the impact of error in the "gold standard" on the observed diagnostic accuracy of surrogate markers. We calculated the area under the receiver operating characteristic curve (AUROC) for a surrogate marker against the gold standard (biopsy) for a range of possible performances of each test (biopsy and marker) against truth and a gradient of clinically significant disease prevalence. In the 'best' scenario where liver biopsy accuracy is highest (sensitivity and specificity of biopsy are 90%) and the prevalence of significant disease 40%, the calculated AUROC would be 0.90 for a perfect marker (99% actual accuracy) which is within the range of what has already been observed. With lower biopsy sensitivity and specificity, AUROC determinations > 0.90 could not be achieved even for a marker that perfectly measured disease. We demonstrate that error in the liver biopsy result itself makes it impossible to distinguish a perfect surrogate from ones that are now judged by some as clinically unacceptable. An alternative gold standard is needed to assess the accuracy of tests used to stage HCV-related liver disease.
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              National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C: 2002--June 10-12, 2002.

              (2002)
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                Author and article information

                Journal
                Ann Gastroenterol
                Ann Gastroenterol
                AnnGastroenterol
                Annals of Gastroenterology : Quarterly Publication of the Hellenic Society of Gastroenterology
                Hellenic Society of Gastroenterology (Greece )
                1108-7471
                1792-7463
                Apr-Jun 2015
                : 28
                : 2
                : 265-270
                Affiliations
                [a ]Division of Gastroenterology and Hepatology (Rafie Yakoob, Ragesh Babu Thandassery, Moutaz F. Derbala, Muneera J. Al Mohannadi, Anil K. John, Manik Sharma, Hamidulla Wani, Saad Al Kaabi), Hamad General Hospital, Doha, Qatar
                [b ]Department of Laboratory Medicine and Pathology (Issam Al Bozom), Hamad General Hospital, Doha, Qatar
                [c ]Department of Biochemistry (Mohamed Osman Abdel Rahman), Hamad General Hospital, Doha, Qatar
                Author notes
                Correspondence to: Ragesh Babu Thandassery, Division of Gastroenterology and Hepatology, Hamad General Hospital, Doha, Qatar, e-mail: doc.ragesh@ 123456gmail.com

                Guarantor of the article: Rafie Yakoob

                Article
                AnnGastroenterol-28-265
                4367218
                25830472
                2a48fafb-1aa2-463a-be83-3aecd4ec8966
                Copyright: © Hellenic Society of Gastroenterology

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 21 June 2014
                : 08 August 2014
                Categories
                Original Article

                liver biopsy,actitest,fibrotest,hepatitis c virus
                liver biopsy, actitest, fibrotest, hepatitis c virus

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