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两种基于自动化实时 PCR 的全血 Epstein-Barr 病毒载量定量方法的评估。

Evaluation of two automated real-time PCR-based quantification methods for whole blood Epstein-Barr viral load.

机构信息

Laboratory of Microbiology and infection control, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.

Laboratory of Microbiology and infection control, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.

出版信息

Diagn Microbiol Infect Dis. 2024 Feb;108(2):116101. doi: 10.1016/j.diagmicrobio.2023.116101. Epub 2023 Oct 8.

DOI:10.1016/j.diagmicrobio.2023.116101
PMID:38016384
Abstract

Quantification of EBV DNA is important in transplantation settings for the diagnosis of post-transplantation. We evaluated the performance of the AltoStar® EBV PCR Kit 1.5 on whole blood specimens: limit of detection, linearity, accuracy, and precision were determined using the WHO NIBSC 09/260 international standard. Results of 69 clinical samples were compared between the AltoStar® EBV PCR Kit 1.5 (altona Diagnostics) and the RealTime EBV assay (Abbott). The LoD of the AltoStar® Kit was 148 IU/mL and linearity was between 375 and 500000. A high concordance was found between nominal value of the NIBSC dilutions and the AltoStar EBV result. The total variation ranged from 2.2% to 9.6%. Out of 69 clinical samples tested, there was a high concordance between the 22 paired results within the overlapping linear ranges of both tests. The AltoStar® EBV assay is reliable and accurate for EBV viral load determination on whole blood samples.

摘要

在移植环境中,定量检测 EBV DNA 对于诊断移植后 EBV 感染非常重要。我们评估了 AltoStar® EBV PCR Kit 1.5 在全血标本中的性能:使用世界卫生组织 NIBSC 09/260 国际标准测定检测限、线性度、准确性和精密度。将 AltoStar® EBV PCR Kit 1.5(altona Diagnostics)和 RealTime EBV 检测试剂盒(Abbott)的 69 份临床样本检测结果进行了比较。AltoStar®试剂盒的检测限为 148 IU/ml,线性范围为 375 至 500000。NIBSC 稀释液的标称值与 AltoStar EBV 结果高度一致。总变异度为 2.2%至 9.6%。在检测的 69 份临床样本中,在两种检测方法的重叠线性范围内,有 22 对检测结果高度一致。AltoStar® EBV 检测试剂盒可用于全血样本 EBV 病毒载量的可靠、准确的测定。

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