全新HCV抗体检测方法与检测策略.ppt

当评价结果不符合某项规则时 警报规则 = 对质控数据点进行其他规则的审查 拒绝规则 = “不符合质控标准” 停止检测 明确并修正问题 对患者样本及质控材料重新进行检测 在问题得到解决，并且质控结果显示状况良好之前不得报告任何病例的检测结果 谢谢！ * * * * Values cover medical decision points – often use high and low, or normal and abnormal * 1. QC Sample The Sources of QC Samples QC samples can be obtained from a number of different sources: Producing your own external control - requires resources because there are many validation and testing steps. Can produce very large volumes with exact specifications. Selecting a diagnostic sample - must meet QC sample requirements. Cheaper option but difficult to get very large volumes so may have to change QC samples often. This will inhibit the collection of longitudinal and batch to batch data. Obtaining a QC sample form another laboratory - saves time, but does not guarantee a well standardised and validated product. Collaboration between laboratories assists in providing the large volume required and may decrease costs. Samples provided as participation in an External QC Programme -this is the preferable option as it provides follow up and feedback on your performance in comparison to other laboratories. Commercially available controls - e.g. BBI Accurun (Boston Biomedica Inc) are purchased by the millilitre and are expensive. Samples are ‘stand alone’ because no results are collected and no feedback is provided. BBI Accurun is a very stable sample due to its production process which involves heat treatment. Because of this the sample is not as sensitive to small fluctuations and may only identify large shifts in variation shifts, similar to the positive control. 方法 生产厂商 酶联免疫法(ELIsA) 27（国外3家）家 化学发光方法 美国强生公司、德国罗氏诊断公司、美国雅培公司；国内已注册的生产厂家有苏州新波公司、科美东雅公司等4家。 蛋白芯片技术 深圳益生堂 胶体金技术 国产的7家；进口注册只有韩国一家。 重组免疫印迹法（RIBA） 凯荣、MP、厦大与万泰合作的。 HCV免疫学检测试剂 检测目的 检测方法 检测策略及 结果报告 检测的意义 HCV抗原检测 HCV抗原检测 检测目的 HCV感染的早期诊断：窗口期，HCV（+）母亲所生的婴儿； 免疫受损或缺陷； 抗-HCV阳性患者的病毒血症分析； 以流行病监测为目的的检测是为了解不同人群HCV感染率及其变化趋势。 HCV抗原检测的方法发展：一 HCV抗原检测原理示意图 检测策略及 结果报告 HCV抗原检测