Rosse Delphine, Garrigou Olivia, Ortonne Valérie, Ingiliz Patrick, Leroy Vincent, Pawlotsky Jean-Michel, Chevaliez Stéphane
French National Reference Center for Hepatitis B, C and delta Viruses, Department of Virology, Hôpital Henri Mondor, Créteil, France; INSERM U955, Créteil, France.
Department of Hepatology, Hôpital Henri Mondor; INSERM U955, Créteil, France.
Diagn Microbiol Infect Dis. 2026 Jan;114(1):117099. doi: 10.1016/j.diagmicrobio.2025.117099. Epub 2025 Sep 4.
Measurement of hepatitis B virus (HBV) DNA levels is the standard of care for diagnosis active HBV infection, assessing disease severity and prognosis, and guiding treatment decisions and monitoring response to therapy. In the study, the analytical and clinical performance of the ELITe InGenius System for quantifying HBV DNA was evaluated. A total of 377 of archived EDTA plasma or serum specimens were tested. The HBV ELITe MGB Kit demonstrated linear quantification of HBV DNA with high precision. The specificity was 100 %. There was a satisfactory correlation with the cobas HBV Test, including patients on antiviral treatment with nucleos(t)ide analogues. The HBV ELITe MGB Kit using the ELITe InGenius System is suitable to detect and quantify HBV DNA in HBsAg-positive patients across the entire quantification dynamic range.
检测乙肝病毒（HBV）DNA水平是诊断活动性HBV感染、评估疾病严重程度和预后、指导治疗决策以及监测治疗反应的标准医疗手段。在该研究中，对ELITe InGenius系统定量检测HBV DNA的分析性能和临床性能进行了评估。共检测了377份存档的乙二胺四乙酸（EDTA）血浆或血清标本。HBV ELITe MGB试剂盒对HBV DNA进行了高精度的线性定量检测。特异性为100%。与cobas HBV检测具有良好的相关性，包括接受核苷（酸）类似物抗病毒治疗的患者。使用ELITe InGenius系统的HBV ELITe MGB试剂盒适用于在整个定量动态范围内检测和定量HBsAg阳性患者的HBV DNA。
