用于定量检测临床标本中人类疱疹病毒6型DNA的自动化系统评估
Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens.
作者信息
Mah Jordan, Huang ChunHong, Sahoo Malaya K, Pinsky Benjamin A
机构信息
Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA, USA.
出版信息
Pract Lab Med. 2023 Aug 5;36:e00329. doi: 10.1016/j.plabm.2023.e00329. eCollection 2023 Aug.
BACKGROUND
Quantitation of human herpesvirus-6 (HHV-6) DNA in clinical specimens is important for the diagnosis and management of HHV-6-associated infection and reactivation in immunocompromised patients, particularly transplant recipients.
METHODS
The analytical performance of the Altona RealStar ASR HHV-6 qPCR on the semi-automated AltoStar AM16 system was assessed using HHV-6 reference material in plasma and cerebral spinal fluid (CSF). Qualitative and quantitative agreement was determined using 123 clinical EDTA plasma specimens tested using a laboratory-developed HHV-6 qPCR.
RESULTS
The 95% Lower Limit of Detection was 20 IU/mL [95% confidence interval (CI): 10 to 29] in plasma and 78 IU/mL (95% CI: 55 to 146) in CSF. The assay was linear from 7.0 to 2.0 log IU/mL in both matrices. Overall agreement of the RealStar ASR HHV-6 qPCR on the AltoStar AM16 with a laboratory-developed test was 95.9% (95% CI: 90.8 to 98.7). Passing-Bablok analysis of specimens quantifiable by both methods and at levels >1000 copies/mL revealed a regression line of Y = 1.00*X-0.20, with neither systematic (95% CI Y-intercept: -0.66 to 0.26) nor proportional (95% CI slope: 0.89 to 1.10) bias compared to the reference.
CONCLUSIONS
The RealStar ASR HHV-6 qPCR on the AltoStar AM16 provides accurate quantitation for clinical monitoring of HHV-6 in immunocompromised hosts.
背景
对临床标本中的人类疱疹病毒6型（HHV-6）DNA进行定量分析，对于免疫功能低下患者，尤其是移植受者，诊断和管理HHV-6相关感染及再激活至关重要。
方法
在半自动AltoStar AM16系统上，使用血浆和脑脊液（CSF）中的HHV-6参考物质评估Altona RealStar ASR HHV-6 qPCR的分析性能。使用实验室自行开发的HHV-6 qPCR检测123份临床乙二胺四乙酸（EDTA）血浆标本，确定定性和定量一致性。
结果
血浆中95%检测下限为20 IU/mL [95%置信区间（CI）：10至29]，脑脊液中为78 IU/mL（95% CI：55至146）。两种基质中该检测方法在7.0至2.0 log IU/mL范围内呈线性。AltoStar AM16上的RealStar ASR HHV-6 qPCR与实验室自行开发检测方法的总体一致性为95.9%（95% CI：90.8至98.7）。对两种方法均可定量且水平>1000拷贝/mL的标本进行Passing-Bablok分析，结果显示回归线为Y = 1.00*X - 0.20，与参考相比，既无系统偏差（95% CI Y轴截距：-0.66至0.26）也无比例偏差（95% CI斜率：0.89至1.10）。
结论
AltoStar AM16上的RealStar ASR HHV-6 qPCR可为免疫功能低下宿主中HHV-6的临床监测提供准确的定量分析。
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