在缅甸评估 GeneXpert 和 Advanced Biological Laboratories UltraGene HCV 诊断仪的检测结果以及与罗氏实时 PCR 相比的性能

IF 4 3区 医学 Q2 VIROLOGY Journal of Clinical Virology Pub Date : 2024-02-12 DOI:10.1016/j.jcv.2024.105653
Pedro Pisa , Constance Wose Kinge , Charles Chasela , Eula Mothibi , Yin Min Thaung , Hnin T. Thwin , Nay M. Aung , Kara W. Chew , Malini M. Gandhi , Cavenaugh Clint , Thomas Minior , Aye A. Lwin , Morgan J. Freiman , Khin P. Kyi , Yi Y. Sein , Fadzai Marange , Charles van der Horst , Sofiane Mohamed , Matthieu Barralon , Ian Sanne
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引用次数: 0

摘要

背景发展中国家由于各种原因,获得 HCV 实验室检测的机会有限。为包括农村地区在内的高危人群提供近乎实时的 HCV 检测和结果是及时开始治疗的关键。在缅甸农村地区,我们比较了 GeneXpert 和 Advanced Biological Laboratories UltraGene-HCV 检测方法与罗氏实时 HCV 黄金标准和参考方法的 HCV 诊断检测和定量结果。对结果进行了正态性检查和对数转换。计算方法之间的对数差异和偏差,并进行相关分析。皮尔逊相关系数用于确定所有方法中 HCV 病毒载量的相关性。结果所有三种方法之间都有很强的正相关系数,其中 GeneXpert 和罗氏的相关系数最高,r = 0.96,(p<0.001)。与罗氏相比,ABL(平均差异,95 % 的一致性限制;-0.063 和 -1.4 至 1.3 Log10IU/mL)和 GeneXpert(平均差异,95 % 的一致性限制;-0.28 和 -0.7 至 1.8 Log10IU/mL)显示出良好的一致性,GeneXpert 略胜一筹。结论我们证明了 GeneXpert 和 ABL 与罗氏平台相比,在一致性水平方面表现优异且无劣势,支持在发展中国家和资源匮乏的国家使用 POC 检测法作为检测和诊断 HCV 的经济有效的替代方法。
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Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar

Background

Developing countries experience limited access to HCV laboratory tests for different reasons. Providing near to real–time HCV testing and results especially to at–risk populations including those in rural settings for timely initiation to treatment is key. Within a rural Myanmar setting, we compared HCV diagnostic detection and quantification of the GeneXpert, and Advanced Biological Laboratories UltraGene–HCV assays against the gold standard and reference method Roche real–time HCV in Myanmar.

Methods

Blood samples from 158 high–risk individuals were assessed using three different methods at baseline. Results were checked for normality and log transformed. Log differences and bias between methods were calculated and correlated. Pearson's correlation coefficient was used to determine the association of HCV viral loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed using Bland–Altman analyses.

Results

There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, r = 0.96, (p<0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement; -0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to 1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior.

Conclusion

We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.

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来源期刊
Journal of Clinical Virology
Journal of Clinical Virology 医学-病毒学
CiteScore
22.70
自引率
1.10%
发文量
149
审稿时长
24 days
期刊介绍: The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)
期刊最新文献
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