Halfon Philippe, Imbert-Bismut Françoise, Messous Djamila, Antoniotti Gilles, Benchetrit Didier, Cart-Lamy Philippe, Delaporte Gilles, Doutheau Danièle, Klump Théo, Sala Michel, Thibaud Didier, Trepo Elisabeth, Thabut Dominique, Myers Robert P, Poynard Thierry
Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France.
Comp Hepatol. 2002 Dec 30;1(1):3. doi: 10.1186/1476-5926-1-3.
Biochemical markers for liver fibrosis (FibroTest) and necroinflammatory features (ActiTest) are an alternative to liver biopsy in patients with chronic hepatitis C. Our aim was to assess the inter-laboratory variability of these tests, and their 6 components (gamma-glutamyl transpeptidase, alanine aminotransferase, alpha2-macroglobulin, haptoglobin, apolipoprotein A1, and total bilirubin) and to identify factors associated with this variability. RESULTS: Serum of 24 patients with chronic hepatitis C or severe alcoholic liver disease were prospectively recorded and analyzed in one reference center and in 8 additional laboratories. When gamma-glutamyl transpeptidase and alanine aminotransferase were expressed in international units, there was no significant difference between laboratories in the results of FibroTest or ActiTest; kappa statistics were greater than 0.50 with only 0.8% of cases (3/384) with a discordance of more than one stage. The main factor significantly associated with variability was the expression of gamma-glutamyl transpeptidase and alanine aminotransferase, as multiples of upper limit of reference values. The use of standardized method with pyridoxal phosphate reduced the variability of alanine aminotransferase expression, and standardized original Szasz method reduced the variability of gamma-glutamyl transpeptidase expression. CONCLUSIONS: The variability of FibroTest and ActiTest was acceptable without clinical consequences for the prediction of the stage of liver fibrosis and grade of activity. Standardized methods and assay calibration should be used and expression of alanine aminotransferase and gamma-glutamyl transpeptidase in multiples of the upper limit of reference values should not be employed.
肝纤维化生化标志物（FibroTest）和坏死性炎症特征（ActiTest）是慢性丙型肝炎患者肝活检的替代方法。我们的目的是评估这些检测及其6种成分（γ-谷氨酰转肽酶、丙氨酸氨基转移酶、α2-巨球蛋白、触珠蛋白、载脂蛋白A1和总胆红素）的实验室间变异性，并确定与这种变异性相关的因素。结果：前瞻性记录了24例慢性丙型肝炎或严重酒精性肝病患者的血清，并在一个参考中心和另外8个实验室进行分析。当γ-谷氨酰转肽酶和丙氨酸氨基转移酶以国际单位表示时，各实验室FibroTest或ActiTest结果无显著差异；kappa统计量大于0.50，只有0.8%的病例（3/384）不一致超过一个阶段。与变异性显著相关的主要因素是γ-谷氨酰转肽酶和丙氨酸氨基转移酶作为参考值上限倍数的表达。使用磷酸吡哆醛标准化方法降低了丙氨酸氨基转移酶表达的变异性，使用标准化的原始萨斯方法降低了γ-谷氨酰转肽酶表达的变异性。结论：FibroTest和ActiTest的变异性在预测肝纤维化阶段和活动度分级方面是可接受的，无临床后果。应采用标准化方法和检测校准，不应采用丙氨酸氨基转移酶和γ-谷氨酰转肽酶作为参考值上限倍数的表达。
