ISO15189认可实验室血涂片复审筛选标准的研究  

Studies on screening criteria of blood slide review in ISO15189 laboratory accreditation

作　　者：莫和国[1] 隋洪[1] 陈光辉[1] 陈渊博[1] 张瑞雄[1] 蔡锦梅[1] 徐宁[1] 

机构地区：[1]南方医科大学附属小榄医院检验科,广东中山528415

出　　处：《中国医药导报》2011年第23期85-87,共3页China Medical Herald

基　　金：广东省中山市科技局科研立项课题(项目名称:ISO15189认可实验室血涂片复审筛选标准的研究;项目编号:20102A027)

摘　　要：目的:本研究是参与卫生部临检中心ISO15189认可委对血涂片复审筛选标准的研究中的子课题;主要采用SysmexXE-2100五分类血细胞分析仪来评估通过国际血液学复审协作专家组推荐的"血细胞涂片复审41条国际规则"对大样本(3 800份血标本)多项目、多参数检测的实验数据进行统计学分析,提出适合于我院检验科就诊患者使用的血涂片复审规则,为卫生部临检中心ISO15189认可委制订适合我国人群的血涂片复审筛选标准通则提供科学数据。方法:随机检测我院检验科就诊患者血常规标本3 800份,同时涂片做细胞形态观察和人工白细胞分类,按照国际血涂片复审规则及日本Sysmex公司提供的21条规则和涂片镜检阳性标准进行评价,通过对实验数据进行统计学分析,计算出真阳性、假阳性、真阴性、假阴性和涂片复审率,制订符合我科实际的最佳血涂片复审筛选标准。结果:根据"血细胞涂片复审41条国际规则"对检测结果进行统计学分析:真阳性率为13.73%(522/3 800),假阳性率为32.05%(1 218/3 800),真阴性率为51.05%(1 940/3 800),假阴性率为3.11%(120/3 800),涂片复审率为45.78%;按日本Sysmex公司提供的21条规则对检测结果进行统计学分析:真阳性率为11.37%(432/3 800),假阳性率为17.97%(683/3 800),真阴性率为66.58%(2 530/3 800),假阴性率为4.08%(155/3 800),涂片复审率为29.34%;且验证试验结果显示,血液病细胞无漏检。结论:全国各医院检验科根据其实际情况制订本科合理适用的血涂片复审筛选标准规则非常重要,既可保证检测结果质量,又可提高工作效率,同时也是ISO15189认可实验室之必检项目。Objective： To find out the suitable hematology review criteria for the patients in Xiaolan hospital whose analysis of experimental data from Sysmex XE-2100 hematology analyzer. Through the large sample of experiments with many projects and more parameters to analysis the experimental data, put forward the hematology review criteria which is suitable to our hospital in order to work out the hematology review criteria for NCCL. Methods： The total of 3 800 patient samples were respectively detected randomly, the blood smears were observed in cell morphology and their number of WBC were analyzed, base on hematology review criteria suggested by international consensus group, hematology review criteria suggested by Sysmex company （the 21 items）, true positive, false positive, true negative, false negative and the ratio of review quantity were calculated by statistical analysis, then find out the best rules for our hospital. Results： According to ＂the 41 Items of International Review Rules＂, the examination results were calculated by statistical analysis. The true positive ratio （TP）, the false positive ratio （FN）, the true negative ratio （TN）, the false negative ratio （FN） and the blood slide review ratio （BSR） respectively were 13.73% （522/3 800）, 32.05% （1 218/3 800）, 51.05% （1 940/3 800）, 3.11% （120/3 800） and 45.78%. According to ＂the 21 Rules＂ supported by Sysmex company, the examination results were calculated by statistical analysis. The TP, FP, TN, FN and BSR respectively were 11.37% （432/3 800）, 17.97% （683/3 800）, 66.58% （2 530/3 800）, 4.08% （155/3 800） and 29.34%, and immature cells were no omitted. Conclusion： In order to test effectively with higher quality, every clinical laboratory should establish its own blood slide review criteria, which is also necessary for ISO15189 laboratory accreditation.

关 键 词：ISO15189 血涂片复审 筛选标准 血细胞形态学 镜检 

分 类 号：R446.11[医药卫生—诊断学]