医学实验室评审员持续培训评审组长同级转换培训班上海课件.pptVIP

* * * HBV 载量和因HCC/CLD*死亡的关系 样本量 =83,794 协作单位 :-Fox Chase Cancer Centre, Philadelphia USA -中国海门市疾病控制中心 -复旦大学 A 10 year prospective cohort of 83,794 established between 1992 and 1993 in 34 townships, Haimen City, China Screening and entry: All subjects aged 25-64 years at study entry All subjects completed a questionnaire and gave a blood sample Samples were tested for HBsAg at entry Subjects from 9 townships were selected for this analysis 2354 of 3464 subjects had sufficient stored serum samples and complete follow-up information for analysis Serum HBV DNA tested on stored samples Mortality information from death certificate records 448/2354 deaths (231 HCC, 85 CLD and 132 non-liver deaths) * HBV 载量和因HCC/CLD*死亡的关系 样本量 =83,794 协作单位 :-Fox Chase Cancer Centre, Philadelphia USA -中国海门市疾病控制中心 -复旦大学 A 10 year prospective cohort of 83,794 established between 1992 and 1993 in 34 townships, Haimen City, China Screening and entry: All subjects aged 25-64 years at study entry All subjects completed a questionnaire and gave a blood sample Samples were tested for HBsAg at entry Subjects from 9 townships were selected for this analysis 2354 of 3464 subjects had sufficient stored serum samples and complete follow-up information for analysis Serum HBV DNA tested on stored samples Mortality information from death certificate records 448/2354 deaths (231 HCC, 85 CLD and 132 non-liver deaths) * 医学实验室评审员持续培训/ 评审组长同级转换培训班 上海 2009-4-25~26 现场评审的基本思路 基因扩增检验实验室均经过卫生部临床检验中心的技术验收，验收标准又基本参照了ISO15189认可准则的要求，所以，在评审准备要实验室提供验收合格证书 日程安排上不能因通过了技术验收而忽视了PCR实验室的认可 重点关注申请的项目是否都有批文、各项记录是否完善等内容 常见不符合项举例及分析 HBV-DNA可报告范围为103－108，HCV-RNA可报告范围为103－107，标准曲线和室内质控的浓度设定都在104以上，建议观察103低浓度值。 有一位从事临床基因扩增检验工作人员未获得培训合格证书 分区 现场评审的重要环节 检验前程序（PCR技术验收表6－－标本管理） －－验收表比较简单，应注意RNA、分泌物等标本的采集、运输和保存 检验程序（见后） 检验后程序（注意TAT是否满足质量目标的要求；报告单所必须包含的内容） 座谈会（要了解临床对定量HBV-DNA；性病检测） DNA、RNA的保存 DNA标本无菌条件2-8℃保存不超过3天，超过3天- 20 ℃ 。标本长期保存应在-70℃。避免多次反复冻融。DNA在TE缓冲液中（10mmol/L Tris-Hcl，1mmol/L EDT