Huysal Kağan, Budak Yasemin U
Department of Clinical Laboratory, Yuksek Ihtisas Education and Research Hospital, Bursa, Turkey.
Department of Clinical Laboratory, Sevket Yilmaz Education and Research Hospital, Bursa, Turkey.
Biochem Med (Zagreb). 2015 Oct 15;25(3):416-20. doi: 10.11613/BM.2015.042. eCollection 2015.
Glycosylated hemoglobin (HbA1c) concentrations measured in clinical chemistry laboratories show large differences between their interlaboratory reported values. Laboratory measurements of quality performance should be based on quantitative data. The sigma metrics model provides an objective method for the assessment of current HbA1c assays and is useful in quality management planning. The aim of our study was to evaluate the analytical performance of the MQ-2000 PT HbA1c analyzer test results in the context of our operating conditions on the sigma scale.
The coefficient of variation was determined from the calculated mean and standard deviation evaluated from internal quality control (QC) (N=168 days) (Shanghai Huachen Biological Reagent Co. Ltd, China) data, and records of external quality data (KBUDEK, İstanbul, Turkey) measured in the period from May to November 2013 were used to determine the bias. The resulting data and total allowable error rate (TEA=10%) from the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) were used to calculate the sigma level.
The calculated coefficient of variations (CVs) at the two levels, normal (QC1=36.6±2.38 mmol/mol) and pathological (QC2=84.7±2.68 mmol/mol), were 6.5% and 3.1%, respectively. The average bias between the external QC and MQ-2000 PT during the study period was 4.3%. The calculated average sigma value was 1.19.
The MQ-2000 PT HbA1c is a new analyser in the market; there is need for improvement and the method should be controlled with greater attention to ensure quality.
临床化学实验室测定的糖化血红蛋白（HbA1c）浓度在实验室间报告值上存在很大差异。实验室质量性能的测量应基于定量数据。西格玛指标模型为评估当前HbA1c检测方法提供了一种客观方法，并且在质量管理规划中很有用。我们研究的目的是在西格玛尺度下，结合我们的操作条件评估MQ-2000 PT HbA1c分析仪检测结果的分析性能。
变异系数由内部质量控制（QC）（N = 168天）（中国上海华臣生物试剂有限公司）数据计算得出的均值和标准差确定，2013年5月至11月期间测量的外部质量数据记录（土耳其伊斯坦布尔KBUDEK）用于确定偏差。所得数据和1988年《临床实验室改进修正案》（CLIA'88）的总允许误差率（TEA = 10%）用于计算西格玛水平。
在正常（QC1 = 36.6±2.38 mmol/mol）和病理（QC2 = 84.7±2.68 mmol/mol）两个水平下计算出的变异系数（CV）分别为6.5%和3.1%。研究期间外部QC与MQ-2000 PT之间的平均偏差为4.3%。计算出的平均西格玛值为1.19。
MQ-2000 PT HbA1c是市场上的一种新型分析仪；需要改进，并且应更加注重控制该方法以确保质量。
