National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P. R. China.
Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, P. R. China.
Microbiol Spectr. 2022 Aug 31;10(4):e0176122. doi: 10.1128/spectrum.01761-22. Epub 2022 Jul 26.
Analytical performance of hepatitis B virus (HBV) DNA quantitative assay is critical for screening infection and initiating and monitoring antiviral treatment. In this study, the limit of detection (LoD) and linearity of Aptima HBV Quant assay were evaluated, and analytical performance was compared with that of the Abbott RealTime M2000 HBV Quant assay and the Procleix Ultrio Plus dHBV assay in plasma samples. The LoDs for genotypes B, C, and D plasma samples were 2.139 (1.531, 4.520), 3.120 (2.140, 7.373), and 3.330 (2.589, 4.907) IU/mL, respectively. The value fitted by linear regression of serially diluted samples less than 2,000 IU/mL was above 0.9. There was no difference in positive rate between Aptima and Abbott or between Aptima and Procleix. Quantitative results of Aptima and Abbott showed good correlation with an of >0.9 using Spearman analysis, while the quantitative results of Aptima were slightly lower than those of Abbott. Usual mutations in the HBV S region had no impact on Aptima assay. This study showed that Aptima is a dual-targeted transcription-mediated amplification (TMA) assay suitable for HBV DNA detection in clinical practice, with quantitative performance comparable to that of the Abbott RealTime M2000 HBV Quant assay and qualitative performance comparable to that of the Procleix Ultrio Plus dHBV assay. The Aptima HBV Quant assay (Hologic Inc., San Diego, CA, USA) is a dual-target real-time transcription-mediated amplification (RT-TMA) assay. This study aims to evaluate whether this assay is suitable for HBV DNA detection. As a result, the assay showed high sensitivity with LoDs below 3.5 IU/mL. The amplification efficiency of Aptima for samples below 2,000 IU/mL is adequate for clinical practice, with an of >0.9 fitted by linear regression. Usual mutations in the HBV S region did not affect the performance of Aptima. Moreover, its performance was comparable to the widely used Abbott RealTime M2000 HBV Quant assay for detecting HBV DNA in plasma specimens. Although not indicated for use as a diagnostic or blood screening assay, the Aptima HBV Quant assay demonstrated comparable qualitative performance to the Procleix Ultrio Plus dHBV system.
乙型肝炎病毒 (HBV) DNA 定量检测的分析性能对于筛选感染、启动和监测抗病毒治疗至关重要。本研究评估了 Aptima HBV Quant 检测的检测限 (LoD) 和线性度，并将分析性能与 Abbott RealTime M2000 HBV Quant 检测和 Procleix Ultrio Plus dHBV 检测在血浆样本中的性能进行了比较。基因型 B、C 和 D 血浆样本的 LoD 分别为 2.139（1.531，4.520）、3.120（2.140，7.373）和 3.330（2.589，4.907）IU/mL。小于 2,000 IU/mL 的连续稀释样本的线性回归拟合 值大于 0.9。Aptima 与 Abbott 或 Aptima 与 Procleix 的阳性率无差异。Aptima 和 Abbott 的定量结果用 Spearman 分析相关性良好， 值大于 0.9，而 Aptima 的定量结果略低于 Abbott。HBV S 区的常见突变对 Aptima 检测无影响。本研究表明，Aptima 是一种适用于临床实践的双靶点转录介导扩增 (TMA) 检测，定量性能与 Abbott RealTime M2000 HBV Quant 检测相当，定性性能与 Procleix Ultrio Plus dHBV 检测相当。Aptima HBV Quant 检测（Hologic Inc.，圣地亚哥，CA，美国）是一种双靶点实时转录介导扩增（RT-TMA）检测。本研究旨在评估该检测是否适用于 HBV DNA 检测。结果表明，该检测具有低于 3.5 IU/mL 的高灵敏度。对于低于 2,000 IU/mL 的样本，Aptima 的扩增效率足以满足临床实践的需要，线性回归拟合的 值大于 0.9。HBV S 区的常见突变不影响 Aptima 的性能。此外，它在检测血浆标本中的 HBV DNA 方面的性能与广泛使用的 Abbott RealTime M2000 HBV Quant 检测相当。尽管不建议将 Aptima HBV Quant 检测作为诊断或血液筛查检测使用，但该检测与 Procleix Ultrio Plus dHBV 系统具有相当的定性性能。
