乙型肝炎病毒DNA定量ELITe InGenius系统的性能

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-09-04 DOI:10.1016/j.diagmicrobio.2025.117099

Delphine Rosse , Olivia Garrigou , Valérie Ortonne , Patrick Ingiliz , Vincent Leroy , Jean-Michel Pawlotsky , Stéphane Chevaliez

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引用次数: 0

摘要

乙型肝炎病毒（HBV） DNA水平的测量是诊断活动性HBV感染、评估疾病严重程度和预后、指导治疗决策和监测治疗反应的护理标准。在这项研究中，评估了ELITe InGenius系统用于HBV DNA定量的分析和临床性能。共检测377份EDTA血浆或血清标本。HBV ELITe MGB试剂盒显示HBV DNA线性定量，精度高。特异性为100%。包括接受核苷(t)类似物抗病毒治疗的患者，与cobas HBV检测有令人满意的相关性。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。

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Performance of the ELITe InGenius system for hepatitis B virus DNA quantification

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.

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.