CAJ | 학술논문

目的分析我国全血细胞计数参考区间现状并与发布的行业标准进行比较.方法通过室间质评软件收集参加2013年第2次全国全血细胞计数室间质评活动实验室的全血细胞计数项目(WBC、RBC、Hb、HCT、MCV、MCH、MCHC和PLT)目前所用参考区间的相关信息,包括参考区间上限和下限,参考区间的来源和参考区间是否验证等.回报结果剔除所有妇幼保健院、儿童医院及公司的数据后,使用Microsoft Excel 2007软件对各项目参考区间的来源和验证情况进行分析;依据国际临床化学联合会指南剔除离群值后使用SPSS13.0软件对参考区间的上限和下限分别进行统计描述,并采用t检验将参考区间的上限和下限与行业标准中的参考区间进行比较.结果 518家实验室中,参考区间来源于《全国临床检验操作规程》的有299家(57.72％),来源仪器/试剂厂家说明书有112家(26.62％),其他来源较少;414家(80.00％)实验室没有验证参考区间,258家(50.00％)实验室不知道如何验证;回报的参考区间最大值与最小值的偏差达16％～ 70％,超过1/3实验室RBC、Hb、HCT项目未按性别分别设置参考区间.大部分实验室WBC、MCV项目上限和下限高于行业标准,RBC(男/女)、PLT、Hb(男)项目上限和下限低于行业标准,MCH项目参考区间比行业标准窄,HCT(男/女)、MCHC、Hb(女)在行业标准上限和下限附近波动.结论目前实验室使用的全血细胞计数参考区间较为混乱,与行业标准差异显著,应该首选行业标准中发布的来自中国人群多中心研究建立的参考区间.
목적 분석아국전혈세포계수삼고구간현상병여발포적행업표준진행비교.방법 통과실간질평연건수집삼가2013년제2차전국전혈세포계수실간질평활동실험실적전혈세포계수항목(WBC、RBC、Hb、HCT、MCV、MCH、MCHC화PLT)목전소용삼고구간적상관신식,포괄삼고구간상한화하한,삼고구간적래원화삼고구간시부험증등.회보결과척제소유부유보건원、인동의원급공사적수거후,사용Microsoft Excel 2007연건대각항목삼고구간적래원화험증정황진행분석;의거국제림상화학연합회지남척제리군치후사용SPSS13.0연건대삼고구간적상한화하한분별진행통계묘술,병채용t검험장삼고구간적상한화하한여행업표준중적삼고구간진행비교.결과 518가실험실중,삼고구간래원우《전국림상검험조작규정》적유299가(57.72％),래원의기/시제엄가설명서유112가(26.62％),기타래원교소;414가(80.00％)실험실몰유험증삼고구간,258가(50.00％)실험실불지도여하험증;회보적삼고구간최대치여최소치적편차체16％～ 70％,초과1/3실험실RBC、Hb、HCT항목미안성별분별설치삼고구간.대부분실험실WBC、MCV항목상한화하한고우행업표준,RBC(남/녀)、PLT、Hb(남)항목상한화하한저우행업표준,MCH항목삼고구간비행업표준착,HCT(남/녀)、MCHC、Hb(녀)재행업표준상한화하한부근파동.결론 목전실험실사용적전혈세포계수삼고구간교위혼란,여행업표준차이현저,응해수선행업표준중발포적래자중국인군다중심연구건립적삼고구간.
Objective To analyze the status of reference intervals (RIs) of complete blood cell count (CBC) in China and compare them with the published standards.Methods The RIs information of CBC (containing the items of WBC,RBC,Hb,HCT,MCV,MCH,MCHC and PLT) were collected by the External Quality Assessment (EQA)software from laboratories participated in the Second Complete Blood Cell Count EQA Program in 2013,which including the sources of RIs,the lower and upper limits of RIs and the validation information of RIs.The sources and validation information of RIs were analyzed by Microsoft Excel 2007 using all data except those from maternal and child care service center,children's hospital and corporations.The outliers of limits of RIs were excluded according to the International Federation of Clinical Chemistry(IFCC)guidelines,then data were analyzed by SPSS 13.0.The mean of the upper and lower limits of the RIs were compared with the published standards by the t-test.Results Totally 299 (57.72％) of 518 laboratories reported were using RIs according to National Clinical Laboratory Operation Rules,while 112(26.62％)labs were using RIs from instrument/reagent manufacturer instructions,411 (80.00％)labs did not validate the RIs they used,of which 258 (50.00％) did not know how to validate RIs.The deviation of the maximum and the minimum ranged from 16％ to 70％.More than one third laboratories did not separate RIs of RBC,Hb and HCT according to the gender.The upper and lower limits of WBC and MCV of most laboratories were higher,while those of RBC(male/female),PLT and Hb(male) were lower than that from the published standard.The RIs of MCH was narrower than that from the published standard.Meanwhile,HCT,MCHC (male/female) and Hb (female) were near the upper and lower limits of published standards.Conclusions At present,the RIs of CBC used in laboratories is chaotic,which is significantly different from the published standard.On the basis of standardization,the RIs of published standard result from a multi-center study in Chinese people should be preferred.