三种应用于自动生化分析仪的半胱氨酸蛋白酶抑制剂C试剂的分析性能验证  

Analytical performance of three cysteine proteinase inhibitor c reagents applied in the automatic biochemistry analyzer

作　　者：国秀芝[1] 邱玲[1] 刘荔[1] 寿玮龄[1] 王亚静[1] 任凤琴[1] 张麟[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院检验科,100730

出　　处：《中华检验医学杂志》2011年第6期561-567,共7页Chinese Journal of Laboratory Medicine

摘　　要：目的 对3种应用于自动生化分析仪的颗粒增强免疫透射比浊法（PETIA）检测血Cys C试剂进行分析性能验证,并初步应用于临床.方法 在OlympusAU2700自动生化分析仪上对上海景源、北京利德曼和北京九强公司生产的颗粒增强免疫透射比浊法（PETIA）Cys C试剂（标为A、B、C）进行性能验证,参考CLSI EP6-A、EP15-A、EP7-P方案对3种方法的精密度、线性范围、干扰因素（胆红素、血红蛋白、乳糜）进行评估,并与德灵颗粒增强免疫散射比浊法（PENIA）试剂进行比对.参考CLSI C28-A2方案应用120名表观健康人血清对试剂A、B、C的参考范围进行验证,应用80例门诊患者血清检测结果评估试剂A、B、C与德灵PENIA 法Cys C试剂判定Cys C异常的一致率.结果 试剂A、B、C的批内CV分别为3.08%～3.20%、2.30%～4.15%和1.38%～1.53%,总CV分别为3.29%～3.44%、2.65%～5.18%和1.67%～1.69%,均小于试剂盒声明不精密度;试剂A、B、C的定量测定下限可分别达0.41、0.23、0.07 mg/L,基本满足检测要求;线性范围分别为0.22～7.26 mg/L （r=0.996）,0.20～7.72 mg/L （r=0.999）,0.20～7.62 mg/L （r=0.997）,线性相关均良好.试验浓度内的3种干扰物（胆红素≤684 μmol/L、Hb≤9.7 g/L及乳糜浊度≤6 200 FTU）对试剂C无显著干扰（＜±10%）;胆红素≤684 μmol/L、Hb≤6.79 g/L及乳糜浊度≤6 200 FTU时,对试剂B无显著干扰;胆红素≤684 μmol/L、Hb≤4.85 g/L及乳糜浊度≤1 240 FTU时,对试剂A无显著干扰.对患者乳糜血清标本采用高速离心后,试剂A、B、C测定Cys C浓度较离心前的平均百分偏倚分别为-8.31%、1.52%、1.32%.试剂A、B、C结果与德灵PENIA法试剂的回归方程分别为Y=0.787X＋0.492（R2=0.976）、Y=1.098X＋0.137（R2=0.982）、Y=1.037X＋0.249（R2=0.996）.试剂A、B、C与德灵PENIA 法Cys C试剂判定Cys C异常的一致率分别为80%（Kappa=0.615,P=0.000）、100%（Kappa=1.000,P=0.000）、91.2%（Kappa=0.824,P=0.000）Objective To validate the analytical performance of three Cys C reagents with particle-enhanced turbidimetric immunoassay（PETIA） method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of three Cys C reagents （labeled as A, B, C） with PETIA method from Shanghai Jing Yuan Co., Beijing Leadman Co. and Beijing Jiuqiang Co. on OlympusAU2700 automatic biochemistry analyzer were assessed.According to the standard of CLSI EP6-A, EP15-A and EP7-P, the precision, linearity range, disturbance （bilirubin, hemoglobin, chyle） were assessed, and compared with those of Cys C reagent based on particle-enhanced nephelometric immunoassay（PENIA） from Dade Behring Co.. The reference ranges for Cys C in serum of 120 healthy individual were evaluated.Results The within-run CVs of the three reagents （A, B and C） were 3.08%-3.2%, 2.3%-4.15% and 1.38%-1.53% respectively.The total CV in A, B and C were 3.29%-3.44%, 2.65%-5.18% and 1.67%-1.69% respectively, lower than the stated.Limits of quantitative determination （LOQ） of the three reagents were 0.41, 0.23 and 0.07 mg/L, basically meeting the testing requirement.The linearity range was 0.22-7.26 mg/L（r=0.996）, 0.20-7.72 mg/L（r=0.999）and 0.20-7.62 mg/L（r=0.997）in the three reagents, which demonstrated a sound linear correlation. For interference tests, no remarkable interference （〈±10%） of reagent C was detected when bilirubin≤684 μmol/L, hemoglobin≤9.7 g/L and Chyle turbidity≤6 200 FTU; and no significant interference of reagent B was found when bilirubin≤684 μmol/L, hemoglobin≤6.79 g/L and Chyle turbidity≤6 200 FTU; when bilirubin≤684 μmol/L, hemoglobin≤4.85 g/L and Chyle turbidity≤1 240 FTU reagent A was not interfered significantly. The comparison afte and before the high-speed centrifugation reveals that the average percentage of bias for reagents A, B, C measured Cys C in chylous serum samples of patients was -8.31%, 1.52%, 1.32%, respectively.In method comparison

关 键 词：半胱氨酸蛋白酶抑制剂 指示剂和试剂 散射测浊法和化浊法 自动分析 参考值 

分 类 号：R197.39[医药卫生—卫生事业管理]