血液病毒核酸检测仪器使用前的性能确认

田耘博; 李维; 秦伟斐; 黄霞; 段恒英; 廖红文

doi:10.13201/j.issn.1004-2806-b.2015.02.009

血液病毒核酸检测仪器使用前的性能确认

- 重庆市血液中心(重庆, 400015)
基金项目:
重庆市卫生局科研项目(No:2013-2-158)

详细信息

通讯作者: 田耘博,E-mail:microtian@126.com

中图分类号: R457.1

收稿日期: 2014-06-25

A performance qualification method of blood virus nucleic acid testing instrument before using

- Chongqing Blood Center, Chongqing, 400015, China

More Information

Corresponding author: TIAN Yunbo, E-mail: microtian@126.com

Received Date: 25 June 2014

摘要

摘要: 目的:确认血液病毒核酸检测(NAT)仪器在使用前,其性能可以满足实际检测工作要求。方法:为确认设备的检测灵敏度、特异性、重复性、可靠性和防止污染等性能,设计4个试验组:联检试验组和鉴别试验组,将生理盐水标本和NAT质控品(HBV DNA、HIV-1 RNA、HCV RNA)交叉放置于标本架上,进行NAT联检和鉴别检测;仪器比对组用同一批献血者标本在同类型的2台仪器上进行检测;污染评估试验组用生理盐水作为阴性标本进行NAT联检。结果:所有NAT检测结果均与预期一致。结论:血液病毒核酸检测设的各项性能满足实际检测工作要求。
- 核酸检测 /
- 仪器 /
- 性能确认
Abstract: Objective:To confirm whether the performance of blood virus nucleic acid testing (NAT) instrument before use can satisfy the test requirement. Method:For verify the detection sensitivity, specificity, repeatability, reliability, and prevent pollution of blood virus nucleic acid testing instrument,four experimental groups was designed. Multiplex and discriminatory assays groups:specimens of physiological saline and NAT quality control material (HBV DNA, HIV-1 RNA, HCV RNA) cross placed on shelves, perform multiplex and discriminatory assays. Instrument contrast group using the same specimens on the same type instrument for testing, and prevent pollution group:physiological saline as negative samples for multiplex assays testing. Result:All NAT test results were in line with expectations. Conclusion:Various performance of blood virus nucleic acid testing instrument could satisfy the requirement of actual test work.
- nucleic acid testing /
- instrument /
- performance qualification

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参考文献(12)

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