19项临床生化检验项目的分析前变异和个体内生物学变异

目的 调查19项临床生化项目的分析前变异和个体内生物学变异.方法 募集21名健康成年志愿者,自每名志愿者连续抽取10份血样,用于分析前变异试验,抽血和样品处理考虑左右臂、止血带使用、采血管品牌和类型、离心前后贮存等因素;再自每名志愿者抽取另外3份血样,每份间隔1周,按规定进行样品处理,用于生物学变异试验;用常规方法检测各样品的19项生化项目,利用方差分析原理计算分析前变异和个体内生物学变异.结果 由各种分析前处理造成的系统变异总体小于样品随机变异,样品随机变异是分析前变异的主要分量;Cl、Na、Ca分析前变异较小(GV值＜1%),其他检验项目CV值为1%～7%不等;不同检验项目生物学变异不同,平均生物学变异Cl、Na、Ca较小(CV值＜2%),TB、TG、ALT、CK较大(CV值＞20%),其余检验项目介于两者之间,与国外数据库数据接近;个体内生物学变异存在较大个体差异.结论 本研究得出19项常见生化检验项目在我国实验室情况下的分析前变异和基于国人的个体内生物学变异,研究结果可望在检验结果临床应用和临床检验质量控制中发挥作用.

Preanalytical and intraindividual biological variations of 19 biochemistry analytes

Objective To investigate preanalytical and intraindividual biological variations of 19 biochemistry analytes. Methods For the study of preanalytical variations, 10 consecutive blood specimens were taken from each of 21 individuals and the specimens were taken from different arms and with various evacuated blood tubes and venous occlusion durations and processed with different storages before and after centrifugal separation of serum. Another 3 aliquots of blood, each at an interval of 1 week, were taken from the individuals for the study of intraindividual biological variations. All the serum samples were analyzed in duplicate for 19 biochemistry analytes. Analysis of variance was performed on the results for the estimation of preanalytical and biological variations. Results Various preanalytical treatments or factors caused some systematic variations but random specimen errors were the main contributors of preanalytical variations. Chloride, sodium and calcium showed preanalytical variations of less than 1% and other analytes ranging from 1%-7%. Different analytes showed varied intraindividual biological variations. The least biological variations ( <2% ) were observed on chloride, sodium and calcium and the largest ( >20% ) on bilirubin,triglycerides, alanine aminotransferase and creafine kinase. Conclusions Preanalytical variations under laboratory settings in China and intraindividual biological variations in Chinese for 19 biochemistry analytes have been estimated. These data will be useful in the estimation of measurement uncertainty and the interpretation of clinical laboratory results.