HBV QS-RGQ 与 CAP/CTM HBV v2.0 检测系统在乙型肝炎病毒 DNA 定量检测方面的性能比较。
Performance Comparison of the HBV QS-RGQ and the CAP/CTM HBV v2.0 Assays regarding Hepatitis B Virus DNA Quantification.
机构信息
Molecular Biology Laboratory, Pasteur Institute of Morocco, 1, Place Louis Pasteur, Casablanca 20360, Morocco.
Team of Experimental Oncology and Natural Substances, Cellular and Molecular Immunopharmacology, Sultan Moulay Slimane University, Faculty of Sciences and Technologies, Beni Mellal, Morocco.
出版信息
Biomed Res Int. 2020 Apr 14;2020:4159189. doi: 10.1155/2020/4159189. eCollection 2020.
BACKGROUND
Over 240 million people are chronically infected with hepatitis B virus (HBV), the leading cause of liver cancer worldwide. The quantification of the HBV DNA level is critical for monitoring the efficacy of antiviral treatment of chronic HBV patients.
METHODS
In our study, we compared the performance of the HBV QS-RGQ assay to the CAP/CTM v2.0 test, as a reference method, on 142 Moroccan patients. The analytical performance of the HBV QS-RGQ assay, such as the limit of detection, quantification, precision, reproducibility, and linearity, was determined using dilution series from 10 to 0.1 log IU/mL.
RESULTS
Detection rates and viral loads quantified by the HBV QS-RGQ assay were significantly lower than those from the CAP/CTM v2.0 assay (73.94% vs. 82.39%; 3.34 ± 1.94 log IU/mL vs. 3.91 ± 2.45 log IU/mL; < 0.01). A Bland-Altman plot found a mean difference of (CAP/CTM v2.0 - HBV QS - RGQ) = 0.5717 log IU/mL, with an average range of -1.13 to 2.31 log IU/mL. The two methods demonstrated a high correlation ( = 0.88) for 100 positive samples, a moderate correlation for samples below 2000 IU/mL ( = 0.76), and a very high correlation for the samples above 2000 IU/mL ( = 0.95). Linearity of the QS-RGQ test ranged from 1.07 to 7.51 log IU/mL.
CONCLUSION
The HBV QS-RGQ assay showed a strong correlation, precision, and linearity in comparison with the CAP/CTM v2.0. However, viral loads determined by the HBV QS-RGQ assay were lower than those determined by the CAP/CTM v2.0 assay.
背景
全球超过 2.4 亿人慢性感染乙型肝炎病毒（HBV），这是全球肝癌的主要病因。HBV DNA 水平的定量对于监测慢性 HBV 患者抗病毒治疗的疗效至关重要。
方法
在我们的研究中，我们将 HBV QS-RGQ 检测法与 CAP/CTM v2.0 检测法（参考方法）在 142 名摩洛哥患者中进行了比较。使用 10 至 0.1 log IU/mL 的稀释系列，确定了 HBV QS-RGQ 检测法的分析性能，如检测限、定量、精密度、重现性和线性。
结果
HBV QS-RGQ 检测法的检测率和定量病毒载量明显低于 CAP/CTM v2.0 检测法（73.94% 与 82.39%；3.34 ± 1.94 log IU/mL 与 3.91 ± 2.45 log IU/mL；<0.01）。Bland-Altman 图发现平均差值（CAP/CTM v2.0 - HBV QS-RGQ）= 0.5717 log IU/mL，平均范围为-1.13 至 2.31 log IU/mL。对于 100 个阳性样本，两种方法具有高度相关性（= 0.88），对于低于 2000 IU/mL 的样本具有中度相关性（= 0.76），对于高于 2000 IU/mL 的样本具有非常高的相关性（= 0.95）。QS-RGQ 检测法的线性范围为 1.07 至 7.51 log IU/mL。
结论
与 CAP/CTM v2.0 相比，HBV QS-RGQ 检测法具有较强的相关性、精密度和线性。然而，HBV QS-RGQ 检测法测定的病毒载量低于 CAP/CTM v2.0 检测法。
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