Introduction

Estimation of hepatitis B (HBV) viral load (VL) is critical in hepatitis-B cascade-of-care and at present there is no point of care (POC) molecular assay available for the same. This study evaluated the performance of a new near point of care molecular assay Xpert HBV- VL assay against the approved assays.

Materials & methods

In this study 172 archived previously tested samples, were simultaneously re-tested for HBV DNA on 3 real-time PCR assays: Abbott Real-Time HBV, Roche TaqMan® HBV and Xpert HBV assay.

Results

Out of 172 samples, 119 were previously positive for HBV DNA with a median VL 4.46 (IQR: 1–8.76)log₁₀IU/mL and 53 were HBV DNA negative. Genotyping could be done in 95 (79.8 %) samples and genotype D (83; 87.3 %) was the commonest type. The Xpert assay demonstrated a good correlation with Abbott (R² = 0.94) and Roche (R² = 0.96). On comparison, the mean difference with 95 % Confidence Interval of Xpert assay was −0.018 and −0.043 log₁₀ IU/mL with Abbott and Roche assay, respectively. The overall sensitivity, specificity, negative predictive value, and positive predictive value of the Xpert assay was found 97.5 %, 100 %, 94.65 & 100 % respectively.

Conclusion

Xpert HBV-VL assay which has a potential for near point of care molecular testing has shown excellent performance and found to be a reliable method for HBV DNA quantification.

中文翻译：

---

Xpert HBV 病毒载量 (VL) 检测的性能评估：用于加强和分散管理慢性乙型肝炎 (CHB) 感染的即时分子检测

介绍

乙型肝炎 (HBV) 病毒载量 (VL) 的估计在乙型肝炎级联护理中至关重要，目前还没有可用的即时 (POC) 分子检测方法。本研究评估了一种新的近点护理分子检测 Xpert HBV-VL 检测相对于批准检测的性能。

材料和方法

在这项研究中，172 个存档的先前检测过的样本同时在 3 种实时 PCR 检测中重新检测了 HBV DNA：Abbott Real-Time HBV、Roche TaqMan® HBV 和 Xpert HBV 检测。

结果

在 172 个样本中，119 个以前 HBV DNA 呈阳性，中位 VL 4.46（IQR：1–8.76）log ₁₀ IU/mL，53 个 HBV DNA 阴性。可以在 95 (79.8 %) 个样本中进行基因分型，基因型 D (83; 87.3 %) 是最常见的类型。Xpert 检测证明与雅培 (R ² = 0.94) 和罗氏 (R ² = 0.96)具有良好的相关性。相比之下，雅培和罗氏检测与Xpert 检测的 95% 置信区间的平均差异分别为 -0.018 和 -0.043 log ₁₀ IU/mL。Xpert 检测的总体灵敏度、特异性、阴性预测值和阳性预测值分别为 97.5%、100%、94.65 和 100%。

结论

Xpert HBV-VL 检测具有近点护理分子检测的潜力，已显示出优异的性能，并被发现是一种可靠的 HBV DNA 定量方法。