肝素锂抗凝血浆与血清样本中34项生化检测结果的偏倚评估

目的观察肝素锂对常规生化检测结果的影响，探讨肝素锂抗凝血浆能否用于生化检测以及能否用血清参考范围解释血浆检测结果。方法按美国临床实验室标准化委员会（NCCLS）的《用患者样本进行方法比对及偏倚评估：批准指南》（EP9-A方案），随机抽取40例患者和健康体检者静脉血样本，分别注入红色真空采集管和肝素锂抗凝管中，于同一生化仪中对34项生化项目进行检测，并对结果进行统计学分析。结果34项测定指标中除脂蛋白（a）[Lp（8）]、前白蛋白（PA）、5’一核苷酸酶（5’-NT）、腺苷脱氨酶（ADA）外，其余各项目的相关系数（r）均≥0．975。34项指标中血浆与血清葡萄糖（Glu）、钾（K）、钠（Na）、氯（c1）、磷（P）的平均偏倚〉1／2美国临床医学检验部门修正法规（CLIA’88）允许误差。血浆Lp（a）、PA、5’NT、ADA检测结果与其血清检测结果相比，差异有统计学意义（P〈0．05），平均偏倚均较大，分别为-11．9％、27．68％、-37．03％、29．31％；其余25项指标血浆测定值与血清测定值之间差异均〈1／2CLIA’88允许误差。结论大部分常规生化检验项目可用肝素锂抗凝血浆代替血清，但Glu、K、Na、Cl、P应建立血浆参考范围，其余项目可用血清参考范围解释血浆检测结果。Lp（a）、PA、5’NT、ADA项目不宜用肝素锂抗凝血浆作为样本进行测定。

Bias estimation of 34 biochemistry indexes between anticoagulant plasma with heparin lithium and serum

Objective To observe the influence of heparin lithium on the results of routine biochemistry determination. To study the feasibility of plasma anticoagulated with heparin lithium used for biochemical assay and serum reference range used for analysing plasma results. Methods According to the method comparison and bias estimation using patient samples (Document EP9-A) approved by National Committee for Clinical Laboratory Standards (NCCLS), 40 blood samples of patients and healthy subjects were separately poured into the red vacuum tube and heparin lithium anticoagulant tube. 34 routine biochemistry indexes were determined by the same auto biochemistry analyzer and analyzed statistically. Results Except for apolipoprotein(a) [Lp(a)],prealbumin(PA) ,5'-nucleotidase (5'-NT) and adenosine deaminase (ADA) ,the correlation coefficient (r) of the other indexes was ≥0. 975. Among 34 indexes, the average bias of glucose (Glu), potassium (K), sodium (Na), chlorine (Cl) and phosphrous (P) with plasma was more than 1/2 the Clinical Laboratory Improvement Amendments (CLIA'88) allowable total error (Tea). The main biases of Lp(a), PA, 5'-NT and ADA were- 11.9% ,27.68%, -37.03% and 29.31% respectively. The results had significant difference between plasma and serum(P < 0.05). The bias of the other 25 indexes in serum and plasma was less than 1/2 CLIA'88 Tea. Conclusions Serum could be replaced by plasma with heparin lithium as anticoagulant for most of biochemistry assay. The serum reference range could be used for explaining plasma results except Glu, K, Na, Cl and P,which should establish their related plasma reference range. The plasma with heparin lithium as anticoagulant could not be used for Lp(a) ,PA,5'-NT and ADA determination.