临床病毒学中诊断实验室检测的验证与确认

Verification and validation of diagnostic laboratory tests in clinical virology.

作者信息

Rabenau Holger F, Kessler Harald H, Kortenbusch Marhild, Steinhorst Andreas, Raggam Reinhard B, Berger Annemarie

机构信息

Institute for Medical Virology, Johann Wolfgang Goethe University Frankfurt/Main, Germany.

出版信息

J Clin Virol. 2007 Oct;40(2):93-8. doi: 10.1016/j.jcv.2007.07.009. Epub 2007 Sep 4.

DOI:10.1016/j.jcv.2007.07.009

PMID:17766174

Abstract

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.

摘要

本综述总结了验证和确认程序的主要问题，并描述了临床病毒学中诊断检测验证和确认的最低要求，包括CE/IVD标记以及自行开发（“自制”）的检测或检测系统的说明。它涵盖了常规病毒学实验室中用于检测病毒特异性抗体、检测病毒抗原、检测病毒核酸以及在细胞培养物上分离病毒的有用技术。