摘要
目的探讨血红蛋白(hemoglobin,HGB)、血小板(platelet,PLT)和平均红细胞血红蛋白含量(mean corpuscular hemoglobin,MCH)室内质控限设定的方法及评价候选质控方案。方法使用仪器配套的高、中2水平质控品,对5种候选室内质控限设定方法进行比较,优选适用于HGB、PLT和MCH室内质控控制范围的设定方法。同时,结合实验室参加卫生部临床检验中心2017年第1次全国血细胞计数正确度验证的数据,选定合适的方案。结果统计同一时间段高、中质控品全部室内质控数据,5种候选室内质控限设定方法中,以新批次质控品20个测定数据计算均值作为靶值,以20个测定数据计算的标准差(SD)最小;HGB高、中水平失控次数分别为24次、13次、PLT高、中水平失控次数分别为5次、2次、MCH高、中水平失控次数分别为15次、7次;用前1个批次质控品的变异系数(CV)或前3个批次质控品的加权平均CV计算的SD适中,失控次数减少;用行标WS/T406-2012规定CV与该平均值的乘积计算的SD或依据质控品厂家提供SD较大,HGB、PLT和MCH失控次数均为0。根据候选质控方案CV不同,HGB(N=2)可选择15s或14s规则,PLT(N=2)可选择15s规则,MCH(N=2)可选择15s、14s或13.5s规则。结论用前1个批次质控品的CV或加权平均CV计算的SD值来设定质控的控制范围,更适用于血细胞分析仪室内质控限设定。临床实验室应结合实验室实际情况,建立并验证适合本实验室检测项目个性化质量控制方案。
Objective To explore the method of setting up the limit of internal quality control of hemoglobin(HGB),platelet(PLT)and mean corpuscular hemoglobin(MCH)and the selection of quality control procedures.Methods The quality control products of high,medium levels matching with instruments were measured as the references.The optimal selections of internal quality control for hemoglobin,platelet and mean corpuscular hemoglobin were evaluated by comparing five internal quality control procedures.At the same time,the quality control procedures were selected by using the data analysis of 2017 national trueness verification project of whole blood cell count.Results Taking all internal quality control data of high and medium levels quality control products during the same period into statistic summary,among the five candidate methods of setting up the limit of internal quality control,we took the mean value of 20 measured data of new batch quality control products as the target value.The standard deviation(SD)calculated from 20 measured data was smaller,and the number of out of control at high and medium level were 24 and 13 times,respectively for HGB,while the number were 5 and 2 times,respectively,for PLT,15 and 7 times for MCH.SD calculated by the coefficient of variation(CV)of previous one batch quality control data or weighted averaging CV of previous three batches quality control data was medium,and the number of out of control decreased.SD calculated by CV in line with standard of WS/T406-2012 or given by the manufacturer was larger,with no out of control.According to the different CV of candidate quality control procedures,HGB(N=2)can choose 15 s or 14 s rules,PLT(N=2)can choose 15 s rules,and MCH(n=2)can choose 15 s,14 s or 13 to 5s rules.Conclusion SD calculated by the coefficient of variation(CV)of previous one batch quality control data or weighted averaging CV of previous three batches quality control data is more suitable for blood cell analyzer for internal quality control limit setting.The clinical laboratory
作者
秦妍妍
高志琪
尹弘毅
杨延敏
王清涛
周睿
QIN Yany-an;GAO Zhi-qi;YIN Hong-yi;YANG Yan-min;WANG Qing-tao;ZHOU Rui(Department of Clinical Laboratory,Fengtai Teaching Hospital of Capital Medical University,Beijing 100071,China;Department of Clinical Laboratory,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Beijing Center for Clinical Laboratory,Beijing 100020,China)
出处
《标记免疫分析与临床》
CAS
2019年第10期1762-1766,共5页
Labeled Immunoassays and Clinical Medicine
基金
国家自然基金面上项目(编号:81672074)
首都卫生发展科研专项项目(编号:2016-1-2031)
国家临床重点专科建设项目
北京市医院管理局市属医院医疗质量管理专题研究项目
关键词
红细胞
血红蛋白
平均红细胞血红蛋白含量
室内质控个性化质控方案
Hemoglobin
Platelet
Mean corpuscular hemoglobin
Internal quality control
Individualized quality control plan
