HIV抗体初筛实验室室内质量控制方式的研究

采用同种试剂及同一批号质控血清对全省 13个HIV抗体初筛实验室进行室内质控 ,以设计的 3种质控框架图及反馈质控数据在同一坐标上制作质控图 ,同时对质控图进行评价。结果显示第 1、第 2质控框架图能反映阶段质控的趋势 ,但不能正确表达质控中的失控。第 3质控框架图能反映阶段实验中质控的失控 ,但由于ELISA方法的特殊性 ,试剂盒效期短及每个试剂盒检测次数不超过 2 0次 ,第 3种质控方式还有待进一步研究与完善。

Study on Quality Control of HIV Antibody Primary Sieve Laboratories

The AIDS monitoring centralab in Anhui province had made a quality control on 13 laboratories of HIV antibody primary sieve in the province by using the same type of reagent and the same charge number quality-control blood serum. The centralab designed three types of QC line chart and made the collecting QC data drawn a complete QC diagram in a coordinate system as well as assessed the results. The first and the second QC diagrams can describe the trend in a quality-control stage, but they couldn t describe the runway situation in QC process correctly. The third one can describe the runaway situation in QC process, however, because of the speciality of ELISA method, that is, validity of the reagent case is short and each reagent case could not use more than 20 times, it should be developed and improved further.