化学发光微粒免疫分析法对心肌损伤标志物及BNP检测的方法学性能评价  

Chemiluminescence immunoassay in determination of myocardial injury markers and plasma B-type natriuretic peptide:A performance assessment

作　　者：杨佳[1] 陈丽龙[2] 李顺君[1] 

机构地区：[1]四川省人民医院检验科,四川成都610072 [2]川北医学院医学检验系,四川南充637000

出　　处：《淮海医药》2011年第6期481-482,共2页Journal of Huaihai Medicine

摘　　要：目的用化学发光微粒免疫分析(CMIA)法测定血浆B型钠尿肽(BNP)和血清肌钙蛋白(TPI)、肌红蛋白(MYO)、肌酸激酶(CKMB),从而了解其检测性能。方法用雅培公司的i2000SR化学发光分析仪,对该方法的精密度、准确度、线性、抗干扰能力、携带污染率、灵敏度进行评价,并验证各项目的参考值区间。结果 (1)CMIA法测定TPI、CKMB、MYO及BNP的批内和批间精密度,批内精密度的CV值均小于5.5%,批间精密度的CV值均小于7.5%。(2)TPI、CKMB、MYO及BNP的准确度测定值与靶值的偏倚在0.6%～4.8%之间。(3)BNP、TPI、CKMB、MYO线性验证回收率均在90%～110%之间。(4)利用高胆红素、高Hb浓度、高TG浓度对心肌三项标志物和BNP进行抗干扰能力测定,心肌三项标志物测定过程中抗干扰能力较强,回收率均在可接受范围内;BNP测定受影响较大,回收率均超出可接受范围。(5)携带污染率实验中,四个项目均表现出良好的抗污染能力。(6)i2000SR对四个项目检测的分析灵敏度(最低检测限)均在厂家提供的范围之内;参考值区间的验证实验,均符合厂家提供的参考范围。结论 CMIA法测定BNP、TPI、CKMB、MYO结果评价其精密度和准确度、线性、抗干扰能力、携带污染率、灵敏度,均表现出良好的性能结果,满足临床要求。Objective To understand the performance and value of chemiluminescence immunoassay（CMIA） in the determination of plasma B-type natriuretic peptide（BNP） and serum troponin I（TPI）,myoglobin（MYO） and creatine kinase（CKMB）.Methods Abbott i2000SR chemiluminescence analyzer was applied to test and evaluate the precision,accuracy,linearity,anti-jamming capability,carryover,sensitivity to evaluate and verify the reference value range.Results（1） When CMIA was applied to test the within-and between-batch precision of TPI,CKMB,MYO and BNP,the CV values of within-batch precision were lower than 5.5% and the CV values of between-batch precision lower than 7.5%.（2） The bias between determined accuracy value of TPI,CKMB,MYO,and BNP and the target value was 0.6% to 4.8%.（3） The linear verification recovery rate of BNP,TPI,CKMB and MYO was between 90%~110%.（4） When three myocardial markers and BNP were tested with high bilirubin,high concentration Hb and high concentration TG in terms of anti-jamming capability,the three myocardial markers manifested high anti-jamming capability and the recovery rates were all within the acceptable range.The determination of BNP was much affected and the recovery rates were beyond the acceptable range.（5） In carryover experiment,the 4 projects all showed good anti-pollution ability.（6） i2000SR analysis sensitivity for the detection of the 4 projects（detection limit） was within the range provided by the manufacturer;the reference interval of the validation was are in line with the reference range provided by the manufacturer.Conclusion The performance of CMIA method in determination of BNP,TPI,CKMB,and MYO shows fine results in precision and accuracy,linearity,anti-jamming capability,carryover,sensitivity,and can well meet the clinical requirements.

关 键 词：心肌损伤标志物 B型钠尿肽 方法学性能评价 化学发光微粒免疫分析法 

分 类 号：R446.6[医药卫生—诊断学]