CAJ | 학술논문

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。
목적：위료대위생행업표준WS／T 405‐2012혈세포분석삼고구간중전혈세포계수상관검측지표적삼고구간진행험증，이판단해표준시부괄용우본실험실。방법채용미국림상실험실표준화협회（CLSI）문건C28‐A3중적추천방법，채집40례건강삼고개체적림상혈액표본진행규범화검측화험증분석。결과40례건강삼고개체적18항혈세포분석상관지표[WBC、RBC、혈홍단백（HGB）、혈세포비용（HCT）、홍세포평균체적（MCV）、평균홍세포혈홍단백량（MCH）、평균혈홍단백농도（MCHC）、혈소판（PLT）등]적검측결과초출WS／T 405‐2012혈세포분석삼고구간적개솔균불초과10％（윤허치위대우혹등우90％）。결론위생행업표준WS／T 405‐2012혈세포분석삼고구간가이응용우본림상실험실。위료학보삼고구간적림상괄용성，실험실환응건립합리、완선적삼고구간험증정서。
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 .