梅里埃VIDAS mini免疫分析仪检测血清HCG实验方法评价  

Evaluation of Detection of Serum HCG with BioMérieux VIDAS mini Immunoassay Analyzer

作　　者：何宗忠[1] 龚娅[1] 林林东[1] 朱来凤[1] 史秋霞[1] 沈雪曼[1] 

机构地区：[1]广州军区广州总医院附属157医院检验科,广东广州510510

出　　处：《标记免疫分析与临床》2013年第4期256-260,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的对梅里埃VIDAS mini全自动免疫分析仪检测血清HCG进行实验方法评价。方法应用BIO-RAD质控品评价精密度,并依据CLIA88文件作干扰试验、回收试验,并收集Diasorin LIAISON化学发光免疫分析仪检测血清β-HCG的血清标本26例立即采用梅里埃VIDAS mini全自动免疫分析仪检测HCG作对比性试验。结果 VIDAS mini检测血清HCG的精密度试验表明,重复性好(高、中质控品的CV值分别为5.209%、5.457%),无一失控点;线性范围为2～1500 mIU/mL,灵敏度较高;实测结果与预期值比较,平均回收率达99.50%,在干扰试验中,HCG对血红蛋白、总胆红素、乳糜血的最大偏离分别为4.41%、5.07%、8.64%。与Diasorin LIAISON测定的β-HCG的结果比较其差异虽有统计学意义(t=2.282,P=0.031),但直线相关回归分析显示呈正相关(r=0.998、P<0.001),直线回归方程为:Y=1.3484X-132.08,说明HCG与β-HCG存在很大的相关性,对于临床诊断有较高一致性。结论梅里埃VIDAS mini全自动免疫分析仪检测血清HCG水平灵敏、准确,与Diasorin LIAISON化学发光免疫分析仪的检测结果呈正相关,且可能在急诊、小型医院中更具应用价值。Objective To evaluate the clinical application of detection for serum HCG with bioMerieux VIDAS mini automated immunoassay analyzer. Methods Precision evaluation was carried out with BIO-RAD control materials. Interference test and recovery test were performed under CLIA88 rules. The β-HCG levels in 26 serum samples were detected by Diasorin LIAISON chemiluminescence immunoassay analyzer, and HCG levels were detected by bioMerieux VIDAS mini automatic immunoassay, and the results were compared and analyzed. Results The detection of serum HCG with VIDAS mini analyzer had qualified precision, the CV of the high and the middle control materials were 5. 209% and 5. 457%, respectively. The linearity of serum HCG standard was 2 - 1500 m IU/mL, and the average recovery rate was 99.50%. The maximum deviation of HCG to hemoglobin, total bilirubin, and chyle blood were 4.41%, 5.07%, 8.64%, respectively. The serum β-HCG levels detected by Diasorin LIAISON was positively correlated with the serum HCG levels detected by VIDAS mini （Y = 1. 3484X-132.08, r = 0. 998, P 〈 0.001 ）. Conclusion Detection of serum HCG level with BioMerieux VIDAS mini automated immunoassay analyzer are sensitive and accurate, and it could be used in the emergency or small hospitals.

关 键 词：血清HCG 梅里埃VIDASmini 实验方法评价 

分 类 号：R446.6[医药卫生—诊断学]