丁型肝炎病毒(HDV)是导致暴发性肝炎和肝功能衰竭的原因,并加速了乙型肝炎病毒(HBV)感染患者的肝硬化和肝细胞癌的发展。迄今为止,治疗依赖于长期给予聚乙二醇化α-干扰素,30%的患者有持续的病毒学应答.最近,新,有希望的抗HDV疗法已经被开发出来,并且已经被用于临床试验。HDVRNA病毒载量(HDVL)监测必须是感染患者管理的组成部分。然而,HDV属的特征是具有很高的遗传变异性,分为八种基因型(HDV-1至-8),和大多数可用的内部或商业测定仅对有限的基因型子集有用。此处报道了用于HDVL定量的新试剂盒的性能与2005年开发的法国国家HDV参考实验室的一致内部测定的比较结果。总共611个具有各种HDVL值的所有HDV基因型的临床样本,包括36名患者几年来的连续样本,被研究过。一种特异性,灵敏度,使用HDV阳性临床样本进行可重复性评估,甲型肝炎,B,C和E(HAV,HBV,HCV,HEV,分别)和艾滋病毒单感染样本,和WHOHDVRNA国际标准。两种测定之间的总体结果严格可比(中位数差异,0.07logIU/ml),具有较高的诊断精度和能力。总之,这种新试剂盒在HDVL的检测/定量方面表现出高性能,不管使用的感染菌株的基因型,并且似乎是患者管理的合适工具。
Hepatitis D virus (HDV) is responsible for fulminant hepatitis and liver failure and accelerates evolution toward cirrhosis and hepatocellular carcinoma in hepatitis B virus (HBV)-infected patients. To date, treatment relies upon long-term administration of pegylated alpha-interferon with a sustained virological response in 30% of the patients. Very recently, new, promising anti-HDV therapies have been developed and are already being used in clinical trials. HDV RNA viral load (HDVL) monitoring must be an integral part of the management of the infected patients. However, HDV genus is characterized by a high genetic variability into eight genotypes (HDV-1 to -8), and most available in-house or commercial assays are useful for only a limited subset of genotypes. Results of a comparison of the performance of a new kit for HDVL
quantification with the
consensus in-house assay of the French National Reference Laboratory for HDV developed in 2005 are reported here. A total of 611 clinical samples of all HDV genotypes with various HDVL values, including several consecutive samples over several years from 36 patients, were studied. A specificity, sensitivity, and reproducibility evaluation was conducted using HDV-positive clinical samples, hepatitis A, B, C and E (HAV, HBV, HCV, and HEV, respectively) and HIV mono-infected samples, and the WHO HDV RNA international standard. Overall results were strictly comparable between the two assays (median difference, 0.07 log IU/ml), with high diagnosis precision and capacity. In summary, this new kit showed high performance in detection/
quantification of HDVL, regardless of the genotype of the infecting strain used, and seems to be a suitable tool for patient management.