颗粒增强免疫透射比浊法测定甲胎蛋白方法学评价  

Methodology evaluation of particle-enhanced turbidimetric immunoassay for determining alpha-fetoprotein

作　　者：曾方银[1] 张豫明[2] 张鹏[1] 林俐[3] 孙德华[1] 

机构地区：[1]南方医科大学南方医院检验科,广东广州510515 [2]南方医科大学附属中西医结合医院检验科,广东广州510315 [3]广东省农垦中心医院检验科,广东湛江524500

出　　处：《检验医学》2012年第11期896-899,共4页Laboratory Medicine

基　　金：广东省自然科学基金资助项目(9451051501003704);广东省科技计划项目(2012A032200016)

摘　　要：目的对定量测定甲胎蛋白(AFP)的颗粒增强免疫透射比浊法(PETIA)进行方法学评价。方法应用OLYMPUS AU5400全自动生化分析仪定量测定AFP,探讨该检测方法的精密度、试剂开瓶稳定性、检测下限、敏感性、线性范围、干扰和准确性;并与SIEMENS CENTAUR电化学发光法(ECLIA)定量测定临床新鲜血清AFP的结果进行相关性分析,同时对其参考区间进行验证。结果 29.95和132.25 ng/mL的新鲜血清测定的批内变异系数(CV)分别为1.67%和1.52%;天间CV分别为7.17%和7.84%;测定下限和敏感性分别为0.52和0.53 ng/mL;5.4～256 ng/mL范围内其测定的线性相关系数(r2)达0.999 4,回归方程为Y=1.014X+1.063 3;高、低水平浓度的定值质控血清测定的相对偏差分别为5.96%和8.40%,远小于卫生部临床检验中心AFP室间质评能力比对试验(PT)评价标准的"靶值±20%";107例临床病例测定结果与SIEMENS化学发光分析仪测定的结果相关性良好,YECLIA=1.138 7XPETIA+2.835 3(r2=0.992 1);一定程度的溶血、黄疸及脂血对该测定无明显干扰;20名健康体检者AFP测定结果均处于厂家推荐的参考区间内。结论 PETIA测定AFP可作为一种简便易行、快捷价廉、准确可靠的临床常规检测方法,特别适合于健康体检时大规模筛查。Objective To evaluate methodologically particle-enhanced turbidimetric immunoassay（PETIA）for determining quantitatively alpha-fetoprotein（AFP）.Methods AFP was determined quantitatively by OLYMPUS AU5400 automatic biochemical analyzer,and the precision,reagent stability,detection low limit,sensitivity,linear range,interference and accuracy of this method were investigated.The correlation of fresh serum sample results between SIEMENS CENTAUR electro-chemiluminescence assay（ECLIA）and PETIA was analyzed.The reference interval was verified.Results Testing 29.95 and 132.25 ng/mL patient samples,the within-run coefficients of variation（CV）were 1.67% and 1.52%,and the day-to-day CV were 7.17% and 7.84% respectively.The detection low limit and sensitivity were 0.52 and 0.53 ng/mL respectively.The linear correlation coefficient（r2）was 0.999 4 from 5.4 to 256 ng/mL,and the regression equation was Y=1.014 X ＋1.063 3.Both of the relative deviations of the high-level serum（5.96%）and low-level serum（8.40%）were lower than the evaluation criteria ＂target value±20%＂ of proficiency testing（PT）from National Center for Clinical Laboratories.There was a good correlation between PETIA with SIEMENS electro-chemiluminescence analyzer in 107 patients,YECLIA=1.138 7XPETIA＋2.835 3（r2=0.992 1）.There was no obvious interference from hemolysis,jaundice and lipidemia.All the results of 20 healthy subject samples were included in the reference interval recommended by the manufacture.Conclusions PETIA is a convenient,rapid,cheap,accurate and reliable method for determining AFP,particularly be suitable for large-scale health screening physical examination.

关 键 词：颗粒增强免疫透射比浊法 甲胎蛋白 方法学评价 

分 类 号：R446.61[医药卫生—诊断学]