不同生化检测系统测定电解质结果的可比性评价

Evaluation of comparability between test results from different biochemical detection systems

目的探讨湿式化学法和干式化学法测定电解质结果的可比性,为同一实验室内两种不同测定系统检测结果提供可比性依据。方法用罗氏P800生化分析仪、原装试剂、校准品、正常和异常水平质控血清组成湿化学法为比较方法;以Fuji DRI-CHEM 7000型干式生化分析仪,原装测试片、校准品和质控品组成干化学法为对比方法,分别用质控血清及患者新鲜血清对钾(K+)、钠(Na+)、氯(Cl-)、钙(Ca2+)进行测定,判断两种检测方法测定结果的可比性。结果两种仪器测定K+,Na+,Cl-,Ca2+经配对t检验,各检测项目的P值均大于>0.05,两种系统的测定结果是一致的;检测结果的批间CV在2.1～4.63间,精密度良好;各项目检测结果偏倚在-1.2%～4.3%之间;各检测结果相关系数均大于0.95。结论此实验证实:两种仪器测定K+,Na+,Cl-,Ca2+,其检测结果具有很好的相关性,在临床患者标本测定结果之间存在较好的可比性,能够满足临床检验的要求。

Objective To investigate the comparability in the electrolyte determination results between wet-chemistry and dry-chemistry methods.Our results can provide comparable reference to laboratory results from the two different methods.Methods Roche P800 biochemical analyzer with original reagent,calibrator,and blood serum at normal and abnormal level were utilized as wet chemistry method.Fuji DRI-CHEM 7000 Biochemical analysis with the original test piece,Calibrator and the dry chemical control materials were utilized as dry-chemistry method.The two methods were used to determine potassium（K＋）,sodium（Na＋）,chlorine（Cl-）,calcium（Ca2＋） from control serum and patients＇ fresh serum.Results of the tests were compared to determine the comparability.Results The t test of K＋,Na＋,Cl-,Ca2＋ from the two methods show that P value of each test is larger than 0.05.The results from the two instrument systems are consistent;CV values of the test are between 2.1 and 4.63,indicating the accuracy;Deviation of each test falls in the region of-1.2%~4.3%;Correlations between each tests are greater than 0.95.Conclusions The results indicate good correlation between the two methods according to the test results of K＋,Na＋,Cl-,Ca2＋.When used in clinical measurements,the results from wet and dry chemistry methods have good comparability which can satisfy the clinical examination requirements.