[巨细胞病毒聚合酶链反应检测结果与全自动系统检测结果的比较：罗氏 Cobas 6800 和 Qiagen NeuMoDx 的经验]。

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-07-01 DOI:10.5578/mb.20249727

Tuğba Bozdemir, Aylin Erman Daloğlu, Dilek Çolak, Nazlı Gürkan, Gözde Öngüt, Derya Mutlu

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引用次数: 0

摘要

病毒载量监测对于确定移植后有可能出现巨细胞病毒（CMV）相关并发症的患者非常重要，为此，最常用的是定量实时聚合酶链反应（Rt-qPCR）检测。CMV DNA 实时聚合酶链反应（Rt-qPCR）定量检测的主要问题是，不同实验室使用不同试剂盒进行的检测结果存在显著差异。随着根据世界卫生组织（WHO）制定的 CMV 国际定量标准（IQS）校准的定量 PCR 检测的推出，实验室间病毒载量测量的可比性得到了提高。然而，使用不同试剂盒进行的测量仍未完全达到定量一致。本研究旨在调查 Cobas 6800（罗氏诊断公司，德国曼海姆）和 NeuMoDx（Qiagen，美国安阿伯）CMV DNA Rt-qPCR 检测试剂盒测量结果之间的定量兼容性。对 214 份血浆样本的结果进行了分析，这些样本同时接受了 Cobas 6800 CMV Rt-qPCR 和 NeuMoDx CMV Rt-qPCR 检测。在这些检测中，提取、扩增和检测阶段都是全自动进行的。在这两种检测方法中，有 144 个样本（67.28%）检测到了 CMV DNA，有 53 个样本（24.76%）未检测到 CMV DNA。共有 17 份（7.94%）样本的检测结果不一致。两种检测方法的定性结果具有良好的一致性（kappa= 0.80，p< 0.001）。如果对两种检测方法在动态测量范围内获得的定量结果（n= 129）进行检查，Cobas 6800 CMV Rt-qPCR 和 NeuMoDx CMV Rt-qPCR 检测方法测得的病毒载量中位值分别为 513 IU/mL（范围= 35-37000）和 741 IU/mL（范围= 68-48978）。根据相关性分析，两种检测结果之间存在很强的相关性（r= 0.94，p< 0.001）。根据Bland-Altman分析，NeuMoDx CMV Rt-qPCR检测结果与Cobas 6800 CMV Rt-qPCR检测结果的平均差异为-0.14 log10 [标准差（SD）= 0.23] IU/mL，并确定Cobas 6800 CMV Rt-qPCR检测结果低于NeuMoDx CMV Rt-qPCR检测结果。在 129 份样本中，有 120 份样本（93%）的结果在两种检测方法的动态测量范围内，其测量差异在 ± 0.5 log10 IU/ml 以内，有 9 份样本（7%）的测量差异超过 ± 0.5 log10（中位数 0.54 log10 IU/ml；范围= 0.51-0.81）。在所有样本中均未发现测量值差异超过 ± 1.0 log10 的情况。在本研究中，全自动 Cobas 6800 CMV Rt-qPCR 和 NeuMoDx CMV Rt-qPCR 检测仪与 CMV IQS 校准血浆样本的定量测量结果一致。据我们所知，在检测 CMV DNA 时比较 Cobas 6800 和 NeuMoDx 全自动系统的病毒载量测量结果的研究还没有进行过，本研究是这方面的第一项研究。

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[Comparison of Cytomegalovirus Polymerase Chain Reaction Test Results Obtained with Fully Automated Systems: Roche Cobas 6800 and Qiagen NeuMoDx Experience].

Viral load monitoring is important in identifying patients at risk of developing cytomegalovirus (CMV) related complications after transplantation and for this purpose, quantitative real-time polymerase chain reaction (Rt-qPCR) tests are most commonly used. The main problem in CMV DNA Rt-qPCR tests that make quantitative measurements is that there are significant differences in measurements performed with different kits in different laboratories. Comparability of viral load measurements between laboratories has increased with the introduction of quantitative PCR tests calibrated with the CMV International Quantitation Standard (IQS) developed by the World Health Organization (WHO). However, quantitative agreement between measurements made with different kits has still not been fully achieved. In this study, it was aimed to investigate the quantitative compatibility between measurements made with Cobas 6800 (Roche Diagnostics, Mannheim, Germany) and NeuMoDx (Qiagen, Ann Arbor, USA) CMV DNA Rt-qPCR tests, which are fully automated new generation systems calibrated with the WHO CMV IQS. The results of 214 plasma samples, which were studied simultaneously with Cobas 6800 CMV Rt-qPCR and NeuMoDx CMV Rt-qPCR tests were analyzed. In the tests, the extraction, amplification and detection stages were carried out fully automatically. CMV DNA was detected in 144 (67.28%) samples in both tests and was not detected in 53 (24.76%) samples. Incompatible results were obtained in a total of 17 (7.94%) samples. Good agreement was found between the qualitative results of both tests (kappa= 0.80, p< 0.001). When the quantitative results (n= 129) obtained in the dynamic measurement range of both tests were examined, the median viral load values measured by Cobas 6800 CMV Rt-qPCR and NeuMoDx CMV Rt-qPCR tests were 513 IU/mL (range= 35-37000) and 741 IU/mL (range= 68-48978), respectively. According to the correlation analysis, a very strong correlation was found between the results of both tests (r= 0.94, p< 0.001). According to Bland-Altman analysis; the average difference between the results of the NeuMoDx CMV Rt-qPCR test and the Cobas 6800 CMV Rt-qPCR test was found to be -0.14 log10 [standard deviation (SD)= 0.23] IU/mL and it was determined that the Cobas 6800 CMV Rt-qPCR test had lower measurements than the NeuMoDx CMV Rt-qPCR test. In 120 of 129 samples (93%) whose results were within the dynamic measurement range of both tests, the measurement difference was within ± 0.5 log10 IU/mL and in 9 (7%), it was detected as more than ± 0.5 log10 (median 0.54 log10 IU/ml; range= 0.51-0.81). No measurement difference of more than ± 1.0 log10 was detected in any sample. In this study, quantitative agreement was found in the measurements made in plasma samples with the fully automated Cobas 6800 CMV Rt-qPCR and NeuMoDx CMV Rt-qPCR tests calibrated with the CMV IQS. To the best of our knowledge, a study comparing viral load measurements made with Cobas 6800 and NeuMoDx fully automated systems in the detection of CMV DNA has not yet been conducted, and this is the first study on this subject.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.