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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >Evaluation of automated nucleic acid extraction devices for application in HCV NAT.
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Evaluation of automated nucleic acid extraction devices for application in HCV NAT.

机译：评估用于HCV NAT的自动核酸提取设备。

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BACKGROUND: To further improve the safety of the blood supply, various national blood transfusion organizations presently use or are in the process of implementing routine HCV NAT in minipools. According to the Committee for Proprietary Medicinal Products (CPMP) of the European Union, the HCV NAT detection limit of the assay should be 100 IU per mL (270 geq/mL) for testing initial plasma pools. Paul Ehrlich Institute (PEI) regulations stipulate that 5000 IU per mL (13,500 geq/mL) must be detected to calculate the amount contributed by individual donations composing the minipool. The sensitivity for HCV RNA extraction achieved by three commercially available laboratory kits was compared. STUDY DESIGN AND METHODS: Nucleic acids from 1-in-3 serial dilutions of an HCV RNA run control (Pelispy, CLB) were extracted with three kits (Cobas Amplicor, Roche Diagnostic Systems; BioRobot 9604, Qiagen; and NucliSens Extractor, Organon Teknika). HCV PCR of all extracts was performed using a second-generation Cobas Amplicor HCV test and the Cobas Amplicor analyzer. RESULTS: The manual Cobas Amplicor, the BioRobot 9604, and the NucliSens Extractor setups allow a 95-percent HCV RNA detection limit of 129, 82, and 12 geq per mL, respectively. The maximal pool size for the manual Cobas Amplicor, the BioRobot 9604, and the NucliSens Extractor kits that would still meet the PEI criteria for HCV NAT in minipools was calculated at 104, 164, and 1125 donations, respectively. CONCLUSION: All three HCV NAT kits evaluated meet the criteria set by CPMP and PEI. The highest sensitivity for HCV NAT screening can be achieved with the high-volume NucliSens Extractor method in combination with the Cobas Amplicor HCV v2.0 test on the Cobas Amplicor analyzer.
机译：背景技术：为了进一步提高血液供应的安全性，各个国家的输血组织目前正在或正在小型池中实施常规HCV NAT。根据欧盟私有药物产品委员会（CPMP）的规定，该HCV NAT检测限应为100 IU / mL（270 geq / mL），以测试初始血浆池。 Paul Ehrlich Institute（PEI）法规规定，必须检测到5000 IU / mL（13,500 geq / mL），才能计算出由微型池组成的单个捐赠所贡献的数量。比较了三种市售实验室试剂盒对HCV RNA提取的敏感性。研究设计和方法：用三种试剂盒（Cobas Amplicor，Roche Diagnostic Systems; BioRobot 9604，Qiagen;和NucliSens Extractor，Organon Teknika）提取了HCV RNA运行对照（Pelispy，CLB）的1：3系列稀释液中的核酸。 ）。使用第二代Cobas Amplicor HCV测试和Cobas Amplicor分析仪进行所有提取物的HCV PCR。结果：手动Cobas Amplicor，BioRobot 9604和NucliSens Extractor设置允许95％的HCV RNA检测极限分别为129、82和12 geq / mL。手动Cobas Amplicor，BioRobot 9604和NucliSens Extractor试剂盒的最大池大小分别达到104、164和1125，分别计算出微型池中的HCV NAT的PEI标准。结论：评估的所有三种HCV NAT试剂盒均符合CPMP和PEI设定的标准。结合大量的NucliSens提取器方法和Cobas Amplicor分析仪上的Cobas Amplicor HCV v2.0测试，可以实现HCV NAT筛选的最高灵敏度。

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