Hologic Aptima HCV Quant Dx assay 对干血斑中 HCV RNA 的检测性能评估。

Performance evaluation of the Hologic Aptima HCV Quant Dx assay for detection of HCV RNA from dried blood spots.

机构信息

NSW State Reference Laboratory for HIV, St Vincent's Centre for Applied Medical Research, Darlinghurst, Sydney, Australia; The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.

NSW State Reference Laboratory for HIV, St Vincent's Centre for Applied Medical Research, Darlinghurst, Sydney, Australia.

出版信息

J Clin Virol. 2019 Mar;112:40-44. doi: 10.1016/j.jcv.2019.01.010. Epub 2019 Jan 25.

DOI:10.1016/j.jcv.2019.01.010

PMID:30776575

Abstract

BACKGROUND

The availability of effective direct-acting antiviral therapy for hepatitis C virus (HCV) has led to a need for simplified diagnostic pathways. Barriers to treatment uptake, specifically in people who inject drugs and in remote and resource limited settings, may be overcome by utilizing novel collection methods, such as dried blood spots (DBS). However, there are currently no registered assays for HCV RNA testing from DBS samples.

OBJECTIVES

To evaluate the sensitivity and specificity of the Aptima HCV Dx Quant assay for HCV RNA detection in DBS samples STUDY DESIGN: 107 paired venepuncture and DBS samples from HCV antibody positive individuals were analyzed for HCV RNA on the Aptima HCV Dx Quant and Roche CAP/CTM (gold standard) HCV assays.

RESULTS

78% (n=83) had detectable HCV RNA in plasma. Sensitivity of the Aptima assay for HCV RNA detection in DBS was 96.4% (95% CI 89.8-99.3%) and specificity was 95.8% (95% CI 78.8-99.9%). Sensitivity for HCV RNA detection in DBS using a quantitative threshold of ≥15 IU/mL in plasma was 95.1% (95% CI 88%-98.7%) and specificity was 96.0% (95% CI 79.7%-99.9%). The sensitivity of HCV RNA detection in DBS using a quantitative threshold of ≥1000 IU/mL (based on a clinically relevant threshold) was 100% (95% CI 95.3-100%) and specificity was 100% (95% CI 88.4-100%).

CONCLUSIONS

Our data indicates that the Aptima HCV Dx Quant can detect active HCV infection from a DBS sample with good sensitivity and specificity, particularly when using a threshold of ≥1000 IU/mL.

摘要

背景

有效的直接作用抗病毒疗法治疗丙型肝炎病毒（HCV）的出现，需要简化诊断途径。在注射毒品者和偏远及资源有限的环境中，治疗的障碍可能会通过利用新的采集方法（如干血斑[DBS]）来克服。然而，目前还没有针对 DBS 样本中 HCV RNA 检测的已注册检测方法。

目的

评估 Aptima HCV Dx Quant 检测试剂盒用于 DBS 样本中 HCV RNA 检测的灵敏度和特异性。

研究设计

对 107 例 HCV 抗体阳性个体的静脉穿刺和 DBS 样本进行分析，采用 Aptima HCV Dx Quant 和 Roche CAP/CTM（金标准）HCV 检测试剂盒检测 HCV RNA。

结果

78%（n=83）的血浆中可检测到 HCV RNA。Aptima 检测试剂盒检测 DBS 中 HCV RNA 的灵敏度为 96.4%（95%CI 89.8-99.3%），特异性为 95.8%（95%CI 78.8-99.9%）。使用血浆中≥15 IU/mL 的定量阈值，DBS 中 HCV RNA 检测的灵敏度为 95.1%（95%CI 88%-98.7%），特异性为 96.0%（95%CI 79.7%-99.9%）。使用基于临床相关阈值的≥1000 IU/mL 的定量阈值，DBS 中 HCV RNA 检测的灵敏度为 100%（95%CI 95.3-100%），特异性为 100%（95%CI 88.4-100%）。