Calibration of HIV-1 working reagents for nucleic acid amplification techniques against the 1st international standard for HIV-1 RNA
Calibration of HIV-1 working reagents for nucleic acid amplification techniques against the 1st international standard for HIV-1 RNA
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DOI：
10.1016/s0166-0934(02)00187-8
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发表时间：
2003-01-01
影响因子：
3.1
通讯作者：
Holmes, H
中科院分区：
文献类型：
--
作者：
Davis, C;Heath, A;Holmes, H
许多实验室使用工作试剂/运行对照来监测核酸扩增技术 (NAT) 的性能，以测量 HIV-1 RNA。为了校准七种国际可用的工作试剂，QC105（澳大利亚国家血清学参考实验室 [NRL]）、B5 和 B10（美国生物评估和研究中心 [CBER]）、Pelispy（荷兰输血服务中心实验室 [CLB]，荷兰）、PWS-1 和 PWS-3（英国国家生物标准与控制研究所 [NIBSC]）和 IRC 进行了一项合作研究。 （病毒学网络 [VN]，荷兰）反对第一个 HIV-1 RNA 国际标准（代码 97/656）。来自12个不同国家的21个实验室参与了合作研究，结果确定QC105含有4.0 log(10)国际单位(IU)/ml、B5 2.2 log(10) IU/ml、B10 3.8 log(10) IU/ml、Pelispy 4.4 log(10) IU/ml、PWS-1 3.6 log(10) IU/ml，PWS-3 2.7 log(10) IU/ml 和 IRC 4.3 log(10) IU/ml。这项国际研究中校准的七种工作试剂可用于验证和标准化目前应用于血液安全和患者管理领域的大量定性和定量、商业和内部 NAT 测定。它们还将帮助实验室遵守监管机构可能提出的敏感性要求，并可能有助于进一步协调欧洲药品评价机构 (EMEA)、Paul-Ehrlich 研究所和 CBER、FDA 等组织发布的 NAT 指南。 (C) 2002 Elsevier Science B.V. 保留所有权利。
Many laboratories use working reagents/run controls to monitor the performance of their nucleic acid amplification techniques (NAT) for the measurement of HIV-1 RNA. A collaborative study was carried out in order to calibrate seven internationally available working reagents, QC105 (National Serology Reference Laboratory [NRL], Australia), B5 and B10 (Center for Biological Evaluation and Research [CBER], USA), Pelispy (Central Laboratory of the Netherlands Blood Transfusion Service [CLB], The Netherlands), PWS-1 and PWS-3 (National Institute for Biological Standards and Control [NIBSC], UK) and IRC (Virology Networks [VN], The Netherlands) against the 1st International Standard for HIV-1 RNA (code 97/656). Twenty-one laboratories from 12 different countries participated in the collaborative study and from the results it was determined that QC105 contained 4.0 log(10) International Units (IU)/ml, B5 2.2 log(10) IU/ml, B10 3.8 log(10) IU/ml, Pelispy 4.4 log(10) IU/ml, PWS-1 3.6 log(10) IU/ml, PWS-3 2.7 log(10) IU/ml and IRC 4.3 log(10) IU/ml. The seven working reagents calibrated in this international study may be used to validate and standardise the large number of qualitative and quantitative, commercial and in-house NAT assays that are currently being applied in the fields of blood safety and patient management. They will also help laboratories to comply with the sensitivity requirements that may be brought in by the regulatory authorities and may contribute to further harmonisation of guidelines on NAT published by organisations such as the European Medicines Evaluation Agency (EMEA), Paul-Ehrlich Institute and CBER, FDA. (C) 2002 Elsevier Science B.V. All rights reserved.