感染性疾病诊断和监测微阵列技术的质量控制

随着越来越多的临床实验室采用微阵列技术(Microarrays)进行诊断性测试，不同类型的微阵列以及它们在临床实验室中的运用突飞猛进。微阵列技术是目前较为新颖的一项技术，主要用于感染性疾病中病原体的检测、鉴定、基因分型以及耐药性的确定。该文以建立微阵列检测的一般要求为起始，按照检验前、检验中和检验后的顺序进行具体说明；同时描述微阵列技术分析性能的验证和确认；提出关于微阵列技术质量控制和质量保证的考虑；并讨论数据分析和解释部分所需的方法和参数。

Quality Control of Microarrays for Diagnosisand Monitoring of Infectious Diseases

With a growing number of clinical laboratories adopted Microarrays for diagnostic testing，the different types of Microarrays and their application in clinical laboratories had improved enormously．Microarrays was a relatively new technology．It mainly deals with infectious pathogen detection，identification，and genotyping，as well as drug resistance determination．This article begins with the general requirements for the establishment of Microarrays，with detailed explanations in the sequence of before，during and after the assay．Meanwhile，it also describes the verification and validation of analytical performance of Microarrays，raises several considerations for the quality control and quality arrurance，and discusses methods and parameters needed for data analysis and interpretation．