两套生化分析系统间血清电解质检测的偏倚评估

Evaluation of exam consistency on serum electrolyte levels by two types of clinical analyzers

目的对雅培Architect C8000全自动生化分析仪、恒星HX-7185电解质分析仪2套生化分析系统间血清电解质(钾、钠、氯)检测进行方法比对和偏倚评估,评价检测结果的一致性。方法依据美国国家临床实验室标准化委员会(NCCLS)EP9-A2文件的要求,每天选取9份血清标本,分别用2套系统测定钾、钠、氯各2次,连续5d,对仪器间的预期偏倚进行评估。结果血清钠预期偏倚的可信区间包含了允许误差,血清钾和氯允许误差大于预期偏倚可信区间的上限,待评方法的预期偏倚小于允许误差的概率很高(>97.5%)。结论 2套生化分析系统间血清电解质(钾、钠、氯)检测在总蛋白及脂类基本正常的标本中有较好的一致性,但总蛋白及脂类过高或过低的标本在两系统的检测差异仍需观察和引起重视。

Objective The purpose for the present study is to clarify whether or not the serum electrolyte levels detected by the two methods（Abbott Architect C8000 automatic biochemical analyzer and the HX 7185 electrolyte analyzer）are consistent. Methods Following the guideline EP9 A2 released by the U. S. National Committee for Clinical Laboratory Standards（NCCLS）, 45 patient serum samples（9 samples per day,for 5 days）were collected,and the levels of K＋ ,Na＋ and Cl＋ in these samples w6re determined and recorded by both approaches mentioned above, the expected inter-instrumental bias was assessed. Results For the serum sodi- um detection, the confidence interval of the expected inter-methodological error covers allowable error. For the serum potassium and chloride examination,the allowable error falls in the range of the confidence interval of the expected inter-methodological error. Taken together,our data indicate the probability that the inter-methodological error between the two analysis methods is less than the allowable error is remarkably high（〉97.5%）. Conclusion The results obtained by the two serum electrolyte detection methods is very consistent in the serum samples in which levels of total serum proteins and lipids are normal. In serum samples with ab normal total protein or lipid levels, however, the inter-methodological error should be paid more attention and closely watched.