循环增强荧光免疫分析技术对β-HCG性能分析在临床的应用评估

Evaluation of the clinical application of circulatory enhanced immunoassay in the analysis of β-HCG performance

目的对某公司的Pylon3D型循环增强荧光分析仪及配套的超宽线性范围的β-HCG试剂盒在临床的应用评估。方法取该所2017年11月16日至2018年2月1日206份来所治疗的患者标本,96份孕妇标本。采用Pylon3D型循环增强荧光分析仪对β-HCG试剂盒的精密度、线性范围、样本回收率、检测限、参考区间及与Abbott公司的试剂盒进行相关性和一致性评估。结果CEFIA法检测高中低样本的轮内和实验室内总不精密度为分别为4.57%~6.06%和4.97%~6.18%。线性范围1~200000IU/L内,线性方程为Y=1.0575X-433,r=0.999,相对偏差范围为1.36%~9.39%。样品回收率为95.46%~107.22%。检出限LoB值为0.28IU/L,LOD值为0.73IU/L。奉贤地区女性第99百分位参考值为4.47IU/L。与Abbott检测结果比对,回归曲线Y=1.037X-0.222,r=0.992,Bland-Altman符合率92.7%。结论利用CEFIA法检测β-HCG具有良好的分析性能,并且其检测线性范围非常广,避免β-HCG普遍需要的样本稀释后重复测试,节约检测成本,在临床应用上具有一定的推广应用价值。

Objective To evaluate the clinical application performance of Pylon 3D immunofluorescent analyzer and wide range β-HCG kit. Methods From November 16th 2017 to February 1st 2018,we took 206 specimens from pregnant women,test precision,linear range,sample recovery,detection capability,reference interval and comparison study with Abbott kit by Pylon 3D immunofluorescent analyzer and kit. Results The within run and within lab precision of high,middle and low samples are 4.57% to 6.06% and 4.97% to 6.18 %.Linear range is 1-200 000 IU/L,regression equation is Y =1.057 5 X -433, r =0.999,relative deviation is around 1.36%-9.39%.Sample recovery is 95.46%-107.22%.LoB is 0.28 IU/L while LOD is 0.73 IU/L.Normal female 99 percentile in fengxian district is 4.47 IU/L.Compare to Abbott,the regression equation is Y =1.037 X -0.222, r =0.992,and the concordance by Bland-Altman is 92.7%. Conclusion This CEFIA based β-HCG assay has good analytical performance,especially its ultra-wide linear range which can avoid dilution test inβ-HCG and save the cost.It's definitely useful in the clinical application.