Verification and validation of diagnostic laboratory tests in clinical virology

被引：81

作者：

Rabenau, Holger F.

Kessler, Harald H.

Kortenbusch, Marhild

Steinhorst, Andreas

Raggam, Reinhard B.

Berger, Annemarie

机构：

[1] Univ Frankfurt, Inst Med Virol, D-60596 Frankfurt, Germany

[2] Med Univ Graz, Mol Diagnost Lab, Inst Hyg Microbiol & Environm Med, Graz, Austria

[3] DACH Deutsch Akkreditierungsstelle Chem, Frankfurt, Germany

来源：

JOURNAL OF CLINICAL VIROLOGY | 2007年 / 40卷 / 02期

关键词：

verification; validation; diagnostics; virology; IVD; CE;

D O I：

10.1016/j.jcv.2007.07.009

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

This review summarizes major issues of verification and validation procedures and describes minimum requirements for verification and validation of diagnostic assays in clinical virology including instructions for CE/IVD-labeled as well as for self-developed ("home-brewed") tests or test systems. It covers techniques useful for detection of virus specific antibodies, for detection of viral antigens, for detection of viral nucleic acids, and for isolation of viruses on cell cultures in the routine virology laboratory. (c) 2007 Elsevier B.V. All rights reserved.

引用

页码：93 / 98

页数：6

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