Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses

Jernej Pav?i?; Alison S. Devonshire; Helen Parkes; Heinz Schimmel; Carole A. Foy; Maria Karczmarczyk; Ion Gutiérrez-Aguirre; Isobella Honeyborne; Jim F. Huggett; Timothy D. McHugh; Mojca Milavec; Heinz Zeichhardt; Jana ?el

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Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses

机译：用于细菌和病毒临床测量的核酸测试的标准化

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Nucleic acid-based tests for infectious diseases currently used in the clinical laboratory and in point-of-care devices are diverse. Measurement challenges associated with standardization of quantitative viral load testing are discussed in relation to human cytomegalovirus, BK virus, and Epstein-Barr virus, while the importance of defining the performance of qualitative methods is illustrated with Mycobacterium tuberculosis and influenza virus. The development of certified reference materials whose values are traceable to higher-order standards and reference measurement procedures, using, for instance, digital PCR, will further contribute to the understanding of analytical performance characteristics and promote clinical data comparability.

机译：当前在临床实验室和即时护理设备中使用的基于核酸的传染病检测方法多种多样。讨论了与人类巨细胞病毒，BK病毒和爱泼斯坦-巴尔病毒有关的定量病毒载量测试标准化带来的测量挑战，而结核分枝杆菌和流感病毒则说明了定性方法的重要性。使用数字PCR等方法开发的值可追溯到高阶标准和参考测量程序的认证参考物质，将进一步有助于理解分析性能特征并促进临床数据可比性。

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《Journal of Clinical Microbiology》 |2015年第7期|共7页
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Jernej Pav?i?; Alison S. Devonshire; Helen Parkes; Heinz Schimmel; Carole A. Foy; Maria Karczmarczyk; Ion Gutiérrez-Aguirre; Isobella Honeyborne; Jim F. Huggett; Timothy D. McHugh; Mojca Milavec; Heinz Zeichhardt; Jana ?el;
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中图分类医学微生物学（病原细菌学、病原微生物学）;
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1. Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses [J] . Jernej Pav?i?, Alison S. Devonshire, Helen Parkes, Journal of Clinical Microbiology . 2015,第7期

机译：用于细菌和病毒临床测量的核酸测试的标准化
2. Differences in Duration and Degree of Cytomegalovirus DNAemia Observed With Two Standardized Quantitative Nucleic Acid Tests and Implications for Clinical Care [J] . The Journal of Infectious Diseases . 2020,第2期

机译：用两个标准化的定量核酸试验观察到患有两个标准化的定量核酸试验的持续时间和程度的差异和临床护理的影响
3. Differences in Duration and Degree of Cytomegalovirus DNAemia Observed With Two Standardized Quantitative Nucleic Acid Tests and Implications for Clinical Care [J] . Meesing Atibordee, Germer Jeffrey J., Yao Joseph D., Autonomic neuroscience: basic & clinical . 2019,第1期

机译：用两种标准化的定量核酸试验观察到患有两种标准化的定量核酸试验的持续时间和程度的差异和临床护理的影响
4. New Insight into Solution Structure and Dynamics of Proteins, Nucleic Acids, and Viruses from Raman Optical Activity [C] . L. D. Barron, E. W. Blanch, A. F. Bell, American Chemical Society . 2002

机译：新洞察蛋白质，核酸和拉曼光学活性的蛋白质，核酸和病毒的新洞察力
5. Type I interferon is not just for viruses: Cytosolic sensing of bacterial nucleic acids. [D] . Monroe, Kathryn McGee. 2011

机译：I型干扰素不仅用于病毒：细菌核酸的胞质感知。
6. Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses [O] . Jernej Pavšič, Alison S. Devonshire, *, 2015

机译：用于细菌和病毒临床测量的核酸测试的标准化
7. Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses [O] . PAVSIC Jernej, DEVONSHIRE A., Parkes H., 2014

机译：用于细菌和病毒临床测量的核酸测试的标准化
8. Guidance for Industry: In the Manufacture and Clinical Evaluation of 'In vitro'211 Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 211 and 2 [R] . 1999

机译：行业指南：制造和临床评估'体外'211检测人类免疫缺陷病毒的核酸序列类型1 211和2

Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses

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