National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Créteil, France.
INSERM U955, Créteil, France.
mSphere. 2022 Jun 29;7(3):e0008222. doi: 10.1128/msphere.00082-22. Epub 2022 Apr 28.
The International Liver Association recommends the use of accurate and sensitive molecular methods for determination of hepatitis B virus (HBV) DNA levels in plasma or serum of chronic HBsAg carriers. The level of HBV replication represents the strongest predictive biomarker associated with disease progression and long-term outcome of chronic HBV infection. The purpose of this study was to evaluate the ability to the new Alinity m System to detect and quantify HBV DNA in plasma and whole blood collected on dried blood spots (DBS). Paired plasma and DBS samples from patients chronically infected with various HBV genotypes were tested in parallel for HBV DNA detection and quantification. There is a linear relationship between HBV DNA levels measured in plasma samples using the Alinity m HBV assay and the Xpert HBV viral load assay, used for comparison. A slight deviation (0.03 ± 0.31 log IU/mL) was observed within the quantitative range. In DBS, HBV DNA levels closely correlated with levels measured in plasma. All patients had detectable and quantifiable HBV DNA by DBS testing, except for one patient with a plasma HBV DNA level above 2,000 IU/mL. In conclusion, the newly developed real-time PCR-based assay Alinity m HBV assay can correctly detect HBV DNA in DBS, especially for patients with blood HBV DNA levels above 2,000 IU/mL, and also accurately quantify HBV DNA in plasma samples. Hepatitis B virus is one of the most prevalent blood-borne viruses affecting the liver and causing acute and chronic hepatitis. Only a small proportion of people with HBV infection are diagnosed. HBV DNA measurement is critical in clinical practice for the diagnosis and treatment decisions of patients requiring antiviral therapy. Dried blood spot (DBS) collection provides a simple, practical, and acceptable alternative to venous blood collection, especially in community settings. We have demonstrated high sensitivity and specificity for HBV DNA detection in DBS compared to plasma samples, especially when using clinically relevant cutoffs of 2,000 and 20,000 IU/mL. Results support the use of DBS in community-based settings.
国际肝脏协会建议使用准确和敏感的分子方法来测定慢性 HBsAg 携带者血浆或血清中的乙型肝炎病毒 (HBV) DNA 水平。HBV 复制水平是与慢性 HBV 感染的疾病进展和长期结局最强相关的预测生物标志物。本研究旨在评估新的 Alinity m 系统在检测和定量检测在采集的干血斑 (DBS) 中血浆和全血中的 HBV DNA 的能力。来自慢性感染各种 HBV 基因型的患者的配对血浆和 DBS 样本平行检测用于 HBV DNA 的检测和定量。使用 Alinity m HBV 检测法测量的血浆样本中的 HBV DNA 水平与用于比较的 Xpert HBV 病毒载量检测法之间存在线性关系。在定量范围内观察到轻微偏差（0.03 ± 0.31 log IU/mL）。在 DBS 中，HBV DNA 水平与在血浆中测量的水平密切相关。除了一名血浆 HBV DNA 水平超过 2,000 IU/mL 的患者外，所有患者均通过 DBS 检测可检测到和定量 HBV DNA。总之，新开发的基于实时 PCR 的 Alinity m HBV 检测法可正确检测 DBS 中的 HBV DNA，特别是对于血液 HBV DNA 水平超过 2,000 IU/mL 的患者，也可准确定量血浆样本中的 HBV DNA。乙型肝炎病毒是最常见的影响肝脏并引起急性和慢性肝炎的血源性病毒之一。只有一小部分 HBV 感染者得到诊断。HBV DNA 测量在临床实践中对于需要抗病毒治疗的患者的诊断和治疗决策至关重要。干血斑 (DBS) 采集提供了一种简单、实用和可接受的替代静脉采血的方法，特别是在社区环境中。与血浆样本相比，我们已经证明了 DBS 中 HBV DNA 的检测具有很高的灵敏度和特异性，特别是当使用 2,000 和 20,000 IU/mL 的临床相关临界值时。结果支持在社区环境中使用 DBS。
