IQC经验介绍.pdf

PCR实验室质控经验介绍 安徽省临床检验中心 凡任芝 1 一、回顾 二、内部质量保证，IQC数据实 验室间比对 三、性能验证 四、外部质量保证 2 一 、回顾 Clinical microbiology Veterinary microbiology Viral load (e.g. HIV, HCV, Viral load (e.g. FIV, CSFV, FCV) HBV) Zoonotic agents Bacterial load (e.g. EHEC, Clinical oncology Salmonella, Minimal residual disease Mycobacterium)Mycobacterium) Chromosomal translocationsChromosomal translocations Fungal load (e.g. Candida, Single nucleotide Cryptococcus, polymorphisms (SNPs) Aspergillus) Gene therapy Food microbiology Gene transfer estimation Bacterial load (e.g. Listeria, Biodistribution of vectors Salmonella, Gene expression Campylobacter) Cytokines, receptors, etc. 3 Box 2. Applications of real-time PCR in molecular diagnosticsa A Note that this list is not exhaustive. 一 、回顾 TRENDS in Molecular Medicine 4 一 、回顾 Scheme of RNA and DNA analysis from biological samples Sources of variation are indicated. M. Kubista et al. / Molecular Aspects of Medicine 27 (2006) 95–125 5 一 、回顾 Hubert et al.12 Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal–part I.J Pharm Biomed Anal. 2004;36:579–586 with permission from Elsevier. 6 一 、回顾 所有基因诊断检测及绝大多数其他分子检测都被归于高度 复杂项目. (美国FDA) ”目前及今后