Comparison of the Amplisure HBV Quantitative Kit with the Qiagen Artus HBV QS-RGQ Assay for Quantifying Viral DNA in Plasma Samples of Monitoring Cases.

IF 3.2 4区医学 Q3 VIROLOGY

Intervirology Pub Date : 2021-01-01 Epub Date: 2021-05-21 DOI:10.1159/000515905

Ganesan Praveenkumar, Chaitali Nikam, Ragoori Venkata Ramana, Sengupta Caesar, Velumani Amruta, Ahmad Riyaj

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引用次数: 1

Abstract

Background: Monitoring of hepatitis B virus (HBV) viral load has become an essential phase in the treatment of HBV. There are many commercial assays available for HBV viral load quantification. In this study, we have evaluated the performance characteristics of Amplisure® HBV Kit in comparison with the Qiagen artus HBV QS-RGQ kit for HBV DNA quantitation.

Methods: Comparison of 2 methods was carried out on 200 clinical samples, 150 HBV DNA positive and 50 HBV DNA negative, by a reference method. Results obtained with Amplisure® HBV Kit (Amplisure HBV) were compared using the Qiagen artus HBV QS-RGQ assay results as the comparator method.

Result: The overall performance of the Amplisure HBV compared with the comparator method shows positive and negative clinical agreement of 100 and 76%, respectively. Among the 12 qualitative discrepant samples, all positive with Amplisure HBV were sequenced and 10 were below comparator method's LOD. For 5 weak positives (-0.22 to 0.98 log IU/mL), the sequencing failed. The 7 other positives (0.48 to 1.89 log IU/mL) were confirmed positive by sequencing. Quantitative comparison gave an r2 of 0.967 with a mean log difference of 0.09 log10 IU/mL.

Conclusion: This study shows that Amplisure® HBV Quantitative Kit shows comparable performance with artus HBV QS-RGQ assays and can be useful in management and therapeutic monitoring of HBV in a clinical practice.

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amplure HBV定量试剂盒与Qiagen Artus HBV QS-RGQ法测定监测病例血浆中病毒DNA的比较

背景:监测乙型肝炎病毒(HBV)病毒载量已成为HBV治疗的重要阶段。有许多商业分析可用于HBV病毒载量定量。在这项研究中，我们评估了Amplisure®HBV Kit与Qiagen artus HBV QS-RGQ试剂盒用于HBV DNA定量的性能特点。方法:采用对照法，对200例临床标本(HBV DNA阳性150例，HBV DNA阴性50例)进行两种检测方法的比较。用Amplisure®HBV Kit (Amplisure HBV)获得的结果以Qiagen artus HBV QS-RGQ检测结果作为比较方法进行比较。结果:Amplisure HBV与comparator方法的总体性能比较，阳性和阴性临床一致性分别为100%和76%。在12个定性差异样本中，所有Amplisure HBV阳性样本均被测序，10个样本低于比较方法的LOD。对于5个弱阳性(-0.22 ~ 0.98 log IU/mL)，测序失败。另外7例阳性(0.48 ~ 1.89 log IU/mL)经测序证实为阳性。定量比较的r2为0.967，平均对数差为0.09 log10 IU/mL。结论:本研究表明Amplisure®HBV定量试剂盒具有与artus HBV QS-RGQ检测相当的性能，可用于临床实践中的HBV管理和治疗监测。

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

Intervirology 医学-病毒学

CiteScore

5.40

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： ''Intervirology'' covers progress in both basic and clinical virus research, and aims to provide a forum for the various disciplines within virology. Issues publishing original papers alternate with thematic issues, focusing on clearly defined topics. This thematic concentration serves to make timely reviews, research reports and controversy easily accessible to both specialists in the field and those who want to keep track of the latest developments outside their own area of interest. In addition to original papers, regular issues publish short communications and letters to the editor to provide readers with a forum for the exchange of ideas and comments. The scope encompasses work on the molecular biology of human and animal viruses, including genome organization and regulation, and the structure and function of viral proteins. The pathogenesis, immunology, diagnosis, epidemiology, prophylaxis and therapy of viral diseases are considered.