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本文引用的文献

1
NucliSens EasyQ HIV-1 V1.2 system: Detection of human plasma-derived background signal.NucliSens EasyQ HIV-1 V1.2 系统:检测人血浆衍生背景信号。
J Virol Methods. 2010 May;165(2):318-9. doi: 10.1016/j.jviromet.2010.02.023. Epub 2010 Feb 26.
2
Correction of underquantification of human immunodeficiency virus type 1 load with the second version of the Roche Cobas AmpliPrep/Cobas TaqMan assay.罗氏 Cobas AmpliPrep/Cobas TaqMan 检测法第二版对人类免疫缺陷病毒 1 载量低估的校正。
J Clin Microbiol. 2010 Apr;48(4):1337-42. doi: 10.1128/JCM.01226-09. Epub 2010 Feb 17.
3
Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA.新罗氏 Cobas AmpliPrep/Cobas TaqMan HIV-1 试验版本 2.0 用于定量检测人类免疫缺陷病毒 1 型 RNA 的性能评估。
J Clin Microbiol. 2010 Apr;48(4):1195-200. doi: 10.1128/JCM.01832-09. Epub 2010 Feb 17.
4
Comparison of the Generic HIV Viral Load assay with the Amplicor HIV-1 monitor v1.5 and Nuclisens HIV-1 EasyQ v1.2 techniques for plasma HIV-1 RNA quantitation of non-B subtypes: the Kesho Bora preparatory study.非 B 亚型血浆 HIV-1 RNA 定量的通用 HIV 病毒载量检测与 Amplicor HIV-1 monitor v1.5 和 Nuclisens HIV-1 EasyQ v1.2 技术的比较:Kesho Bora 预备研究。
J Virol Methods. 2010 Feb;163(2):253-7. doi: 10.1016/j.jviromet.2009.10.005. Epub 2009 Oct 27.
5
Comparative evaluation of the ExaVir Load version 3 reverse transcriptase assay for measurement of human immunodeficiency virus type 1 plasma load.ExaVir Load 版本 3 逆转录酶检测法用于测量人类免疫缺陷病毒 1 型血浆载量的比较评估。
J Clin Microbiol. 2009 Oct;47(10):3266-70. doi: 10.1128/JCM.00715-09. Epub 2009 Aug 5.
6
Performance of the new Roche Cobas AmpliPrep-Cobas TaqMan version 2.0 human immunodeficiency virus type 1 assay.新型罗氏Cobas AmpliPrep - Cobas TaqMan 2.0版1型人类免疫缺陷病毒检测法的性能
J Clin Microbiol. 2009 Oct;47(10):3400-2. doi: 10.1128/JCM.00727-09. Epub 2009 Aug 5.
7
Evaluation of the Abbott m2000 RealTime human immunodeficiency virus type 1 (HIV-1) assay for HIV load monitoring in South Africa compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS EasyQ HIV-1 assays.将雅培m2000实时1型人类免疫缺陷病毒(HIV-1)检测法用于南非HIV病毒载量监测的评估,并与罗氏Cobas AmpliPrep - Cobas Amplicor、罗氏Cobas AmpliPrep - Cobas TaqMan HIV-1以及生物梅里埃NucliSENS EasyQ HIV-1检测法进行比较。
J Clin Microbiol. 2009 Jul;47(7):2209-17. doi: 10.1128/JCM.01761-08. Epub 2009 May 6.
8
Increased reporting of detectable plasma HIV-1 RNA levels at the critical threshold of 50 copies per milliliter with the Taqman assay in comparison to the Amplicor assay.与Amplicor检测法相比,使用Taqman检测法时,每毫升50拷贝这一关键阈值下可检测到的血浆HIV-1 RNA水平报告增加。
J Acquir Immune Defic Syndr. 2009 May 1;51(1):3-6. doi: 10.1097/QAI.0b013e31819e721b.
9
New and old complex recombinant HIV-1 strains among patients with primary infection in 1996-2006 in France: the French ANRS CO06 primo cohort study.1996年至2006年法国初发感染患者中的新旧复杂重组HIV-1毒株:法国国家艾滋病研究机构(ANRS)CO06初发队列研究
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10
Performance of three commercial viral load assays, Versant human immunodeficiency virus type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, testing HIV-1 non-B subtypes and recombinant variants.三种商用病毒载量检测方法的性能,即Versant 1型人类免疫缺陷病毒(HIV-1)RNA分支DNA v3.0、Cobas AmpliPrep/Cobas TaqMan HIV-1和NucliSens HIV-1 EasyQ v1.2,用于检测HIV-1非B亚型和重组变体。
J Clin Microbiol. 2008 Sep;46(9):2918-23. doi: 10.1128/JCM.02414-07. Epub 2008 Jul 2.

使用四种商业实时检测方法比较 HIV-1 载量。

HIV-1 load comparison using four commercial real-time assays.

机构信息

Laboratoire de Virologie, CHU de Saint-Etienne, 42055 Saint-Etienne cedex 02, France.

出版信息

J Clin Microbiol. 2011 Jan;49(1):292-7. doi: 10.1128/JCM.01688-10. Epub 2010 Nov 10.

DOI:10.1128/JCM.01688-10
PMID:21068276
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3020484/
Abstract

The HIV-1 RNA viral load is commonly used for the monitoring of disease progression and antiretroviral treatment of HIV-1-infected patients. Since the misestimating of values could lead to inappropriate therapeutical management, the comparative performances, especially the ability to span the genetic diversity of HIV-1, of available automated real-time assays need to be evaluated. We conducted a prospective study with 74 consenting patients enrolled between March 2007 and November 2008. A blood sample was obtained at the time of diagnosis of HIV seropositivity and blindly tested for HIV-1 RNA by at least 4 commercial tests: the Abbott m2000 RealTime HIV-1, bioMérieux NucliSens EasyQ HIV-1, version 1.2 (v1.2), and Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) v1.0 and v2.0 assays. The means of difference were null between CAP/CTM v2.0 and Abbott for CRF02_AG subtypes but positive in favor of CAP/CTM v2.0 for genotype B and negative in favor of NucliSens for all genotypes. The standard deviation (SD) of difference ranged from 0.3 to 0.59, depending on the considered couples of assays. Reliabilities of these four tests, appreciated by the standard deviation of difference between the measurement and the estimated "true" viral load and by the coefficient of reliability, were significantly different (P < 10(-4)) among each other. Significant differences were also observed within each group of HIV-1 genotype. The global disparity was higher for CRF02_AG than for B subtypes. This study indicates a risk of viral load misestimating or discrepancies between techniques, depending on the HIV-1 subtype, and speaks in favor of using the same assay for the monitoring of HIV-1-infected patients.

摘要

HIV-1 RNA 病毒载量通常用于监测疾病进展和接受抗逆转录病毒治疗的 HIV-1 感染者。由于错误估计值可能导致治疗管理不当,因此需要评估现有自动化实时检测方法的比较性能,特别是跨越 HIV-1 遗传多样性的能力。我们进行了一项前瞻性研究,共纳入 74 名自愿参与的患者,他们于 2007 年 3 月至 2008 年 11 月期间入组。在 HIV 血清学阳性确诊时采集血样,并用至少 4 种商业检测方法对 HIV-1 RNA 进行盲法检测:Abbott m2000 RealTime HIV-1、bioMérieux NucliSens EasyQ HIV-1 v1.2、Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) v1.0 和 v2.0。CRF02_AG 亚型的 CAP/CTM v2.0 和 Abbott 之间的差值平均值为零,但有利于 CAP/CTM v2.0 的结果;而对于基因型 B,差值平均值为正,有利于 CAP/CTM v2.0;对于所有基因型,差值平均值为负,有利于 NucliSens。差异的标准差(SD)范围为 0.3 至 0.59,取决于考虑的检测方法对。通过差值的标准差(即测量值与估计的“真实”病毒载量之间的差异)和可靠性系数来评估这四种检测方法的可靠性,它们彼此之间存在显著差异(P < 0.001)。在每个 HIV-1 基因型组内也观察到显著差异。CRF02_AG 亚型的全球差异高于 B 亚型。这项研究表明,HIV-1 亚型不同时,存在病毒载量估计错误或不同技术之间的差异的风险,因此主张对 HIV-1 感染者进行监测时使用相同的检测方法。