国产全自动生化检测系统的应用评价

Evaluation of the measurement characteristic of domestic automatic chemistry analytical system

目的参照我国全自动生化分析仪行业标准(讨论稿)和美国临床实验室标准化委员会(NCCLS)检测系统性能评价方案,对我国自主研发的全自动生化检测系统进行分析性能的评价,探讨国产检测系统的临床应用价值。方法对上海丰汇公司FH400型全自动生化分析仪、配套试剂和校准品组成的检测系统(简称丰汇检测系统),根据项目的反应原理特征选择丙氨酸氨基转移酶(ALT,零级动力学法)、尿素(Urea,一级动力学法)、总蛋白(TP,二点终点法)和胆固醇(Chol,终点法)进行精密度、线性范围、抗干扰能力实验评价,并与日立全自动生化分析仪与罗氏诊断产品有限公司试剂检测系统作患者样本比对实验。结果丰汇检测系统ALT、Urea、TP和Chol的批内精密度变异系数(CV)中值分别为1.18%、1.35%、0.62%和0.39%,高值分别为0.84%、0.97%、0.34%和0.41%。患者样本比对实验4个项目的相关方程和相关系数(r)分别为ALT:Y=1.068X-0.797,r=0.999;Urea:Y=1.006X+0.181,r=0.999;TP:Y=0.989X+0.629,r=0.997;Chol:Y=1.001X-0.128,r=0.998,其在医学决定水平处的偏倚均低于美国临床实验室改进修正法案(CLIA′88)允许误差范围。线性范围和抗干扰能力[维生素C(VitC)、总胆红素(TBil)、血红蛋白(Hb)和乳糜液]基本符合厂家的声明。结论被评价的丰汇检测系统各项分析性能满足临床使用要求,检测成本较低,有较高的临床应用价值。

Objective To evaluate the measurement characteristic of domestic automatic chemistry analytical system and its clinical application according to the professional standards of automatic chemistry analytical system of our country and the evaluation protocols of National Committee for Clinical Laboratory Standards （NCCLS）. Methods The items including alanine-aminotransferase （ ALT, zero kinetics ）, Urea （ one grade kinetics ）, total protein （ TP, two points） and cholesterol （Chol, endpoint） were selected according to the reaction principle and the precision, linear range and anti-interfere experiments were evaluated by analytical system comprised of the FH400 automatic chemistry analyzer, matching reagents and calibrator of Shanghai Fenghui company. The samples of patients were measured by FH400 automatic chemistry analyzer and compared with the analytical systems comprised of HTACHI automatic chemistry analyzer and the reagents of Roche Diagnostics. Results The medium value of within-run coefficient of variation （CV） of the Fenghui analytical system was 1.18%, 1.35%, 0.62% and 0. 39%. The high value CV was 0.84%, 0.97% ,0.34% and 0. 41%. The relative equation and coefficient of correlation（r） of the ALT, Urea, TP and Chol of patient samples comparative experiments were Y = 1. 068X - 0. 797, r = 0. 999, Y = 1. 006X ＋ 0. 181, r = 0. 999, Y = 0. 989X ＋ 0. 629,r = 0. 997, Y = 1. 001X - 0. 128, r = 0. 998, respectively. The bias at clinical decision level was less than the CLIA＇88 permitted error range. The linear range and anti-interfere ability （vitaminc, total bilirubin , hemoglobin and ehyle） were nearly consistent with the statement of the manufacturer. Conclusions The measurement charac- teristic of evaluated Fenghui automatic chemistry analytical system can fit in with clinical application request. The system has determinate clinical application value and can reduce measurement cost.