成人血细胞分析参考区间适用性验证探讨

摘要

Objective In order to verify the validation of the industry standard WS/T 405‐2012 about adult blood cell analysis reference range ,and ensuring their clinical application .Methods According to Clinical and Laboratory Standards Institute(CLSI) C28‐A3 recommendation method ,40 health reference individuals were enrolled in the study whose blood samples were collected ,de‐tected and analyzed .Results The blood cell analysis indicators involved in the validation included WBC ,RBC ,hemoglobin(HGB) , hematocrit(HCT) ,mean corpuscular volume(MCV) ,mean corpuscular hemoglobin(MCH) ,mean corpuscular hemoglobin concen‐tration(MCHC) ,platelet(PLT ) ,etc .The probability of all results of selected 40 reference individuals beyond the WS/T 405‐2012 blood cell analysis reference interval were no more than 10% (value 90% or higher) .Conclusion The WS/T 405‐2012 blood cell a‐nalysis reference range is suitable for the laboratory .A perfective verification system should be established to ensure its application .%目的：为了对卫生行业标准WS／T 405‐2012血细胞分析参考区间中全血细胞计数相关检测指标的参考区间进行验证，以判断该标准是否适用于本实验室。方法采用美国临床实验室标准化协会（CLSI）文件C28‐A3中的推荐方法，采集40例健康参考个体的临床血液标本进行规范化检测和验证分析。结果40例健康参考个体的18项血细胞分析相关指标[WBC、RBC、血红蛋白（HGB）、血细胞比容（HCT）、红细胞平均体积（MCV）、平均红细胞血红蛋白量（MCH）、平均血红蛋白浓度（MCHC）、血小板（PLT）等]的检测结果超出WS／T 405‐2012血细胞分析参考区间的概率均不超过10％（允许值为大于或等于90％）。结论卫生行业标准WS／T 405‐2012血细胞分析参考区间可以应用于本临床实验室。为了确保参考区间的临床适用性，实验室还应建立合理、完善的参考区间验证程序。