Performance of the cobas 5800 System for Hepatitis B virus DNA and Hepatitis C virus RNA quantification

IF 2.1 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-02-25 DOI:10.1016/j.diagmicrobio.2025.116753

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

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Abstract

Hepatitis B and C infections are an underdiagnosed global health problem. Measurement of HBV DNA or HCV RNA levels using nucleic acid-based molecular diagnostic assays has been established as the standard of care for assessing diagnosis, guiding the treatment decision, and evaluating responses to antiviral therapy.

In the present study, we examined the performance of the cobas 5800 System for HBV DNA and HCV RNA quantification in a large series of patients chronically infected.

Specificity of the cobas HBV and HCV Tests on the 5800 System was high (99.1 % and 100 %, respectively). Linearity using the AcroMetrix panels was excellent. Repeatability and intermediate precision coefficients of variation were within 5 %. Of the 334 clinical specimens tested in parallel on the cobas 5800 and cobas 4800 Systems for HBV and the m2000 RealTime or Alinity m Systems for HCV, only 12 (3.6 %) yielded discrepant results that were at or near the limit of quantification of the cobas 5800 assays. The correlation between viral load results was extremely high, and only weak bias were observed across the entire range of concentrations tested without clinical impact in patients who are eligible for antiviral therapy.

This comparison study demonstrated equivalent performance of the new cobas 5800 System compared with other molecular platforms widely used in clinical practice for HBV DNA and HCV RNA quantification. The cobas 5800 System can be confidently used in clinical practice. A few clinical specimens with low viral loads may be missed. Further studies are warranted to confirm or refute this finding.

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cobas 5800系统用于乙型肝炎病毒DNA和丙型肝炎病毒RNA定量的性能

乙型和丙型肝炎感染是一个未得到充分诊断的全球卫生问题。使用基于核酸的分子诊断检测方法测量HBV DNA或HCV RNA水平已被确立为评估诊断、指导治疗决策和评估抗病毒治疗反应的护理标准。在本研究中，我们检测了cobas 5800系统在大量慢性感染患者中用于HBV DNA和HCV RNA定量的性能。5800系统cobas HBV和HCV检测的特异性高（分别为99.1%和100%）。使用AcroMetrix面板的线性非常好。重复性和中间精密度变异系数在5%以内。在用cobas 5800和cobas 4800系统检测HBV和m2000 RealTime或Alinity m系统检测HCV的334例临床标本中，只有12例（3.6%）的结果与cobas 5800测定法的定量极限相一致或接近。病毒载量结果之间的相关性非常高，并且在符合抗病毒治疗条件的患者中，在整个浓度测试范围内仅观察到弱偏倚。这项比较研究表明，与临床实践中广泛用于HBV DNA和HCV RNA定量的其他分子平台相比，新的cobas 5800系统具有相同的性能。cobas 5800系统可以放心地用于临床实践。一些低病毒载量的临床标本可能会被遗漏。需要进一步的研究来证实或反驳这一发现。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.