雅培Alinity i全自动化学发光免疫分析仪检测乙肝表面抗原及乙肝表面抗体的性能评价

Performance evaluation of Abbott Alinity i immunoassay analyzer for detection of HBsAg and HBsAb

目的:评价雅培Alinity i全自动化学发光免疫分析仪检测乙肝表面抗原(HBsAg)及乙肝表面抗体(HBsAb)的性能。方法:采用Alinity i全自动化学发光免疫分析仪分别检测HBsAg及HBsAb,验证其精密度、线性范围、检出限、功能灵敏度、携带污染率及正常生物参考区间;以雅培Architect i2000全自动化学发光分析仪的检测结果为对照,评价Alinity i全自动化学发光免疫分析仪检测结果与雅培Architect i2000全自动化学发光分析仪检测结果的相关性;采用Alinity i全自动化学发光免疫分析仪检测2021年度卫生部临床检验中心的室间质评样本来判定Alinity i全自动化学发光免疫分析仪与其他实验室检测结果的一致性。结果:Alinity i全自动化学发光免疫分析仪检测HBsAg低、高浓度质控品的批内精密度为3.76%和1.16%,批间精密度为6.72%和3.89%;检测HBsAb低、高浓度质控品的批内精密度为3.81%和3.28%,批间精密度为6.42%和3.78%。在HBsAg及HBsAb的线性回归方程中,相关系数r2分别为0.9958和0.9950,回归方程斜率a分别为0.9881及1.0244。HBsAg及HBsAb的定值质控品稀释到检出限浓度后检测的均值分别为0.0530 IU/mL及2.0755 mIU/mL,CV分别为8.87%和7.89%。HBsAg及HBsAb的功能灵敏度验证浓度分别为0.025 IU/mL以及0.625 mIU/mL。HBsAg与HBsAb的携带污染率皆为0。体检健康者HBsAg及HBsAb的检测结果均落在正常参考范围内。Alinity i全自动化学发光免疫分析仪与Architect i2000全自动化学发光分析仪比对检测HBsAg及HBsAb的线性相关方程相关系数r2分别为0.9982及0.9939,回归方程斜率a分别为0.9568及1.0355。Alinity i全自动化学发光免疫分析仪检测卫生部室间质评样本的结果与预期结果一致。结论:雅培Alinity i全自动化学发光免疫分析仪检测HBsAg及HBsAb的稳定性、重复性和精确性完全符合临床应用要求。

Objective To evaluate the performances of the Abbott Alinity i immunoassay analyzer when applied to the detection of HBsAg and HBsAb.Methods The parameters of the Abbott Alinity i immunoassay analyzer were verified when used to test HBsAg and HBsAb including the precision,linear range,detection limit,functional sensitivity,carryover rate and normal biological reference interval;the results by the Architect i2000 immunoassay analyzer were used as a control to assess the correlation between the results respectively by the Abbott Alinity i and Architect i2000 immunoassay analyzers;the consistency between the results by the Abbott Alinity i immunoassay analyzer and those by other labs was explored by measuring the EQA sample of the national center for clinical laboratories in 2021 with the Abbott Alinity i immunoassay analyzer.Results The within-run precisions of the Alinity i immunoassay analyzer for low and high concentrations of HBsAg were 3.76%and 1.16%,and the between-run precisions were 6.72%and 3.89%,respectively;the within-run precisions of low and high concentrations of HBsAb were 3.81%and 3.28%,and the between-run precisions were 6.42%and 3.78%,respectively.In the linear regression equations for HBsAg and HBsAb,the correlation coefficients r2 were 0.9958 and 0.9950,respectively,and the slopes of the regression equations a were 0.9881 and 1.0244,respectively.The mean values for HBsAg and HBsAb were 0.0530 IU/mL and 2.0755 mIU/mL,and the values of CV were 8.87%and 7.89%,respectively,after the assayed quality control materials diluted to the detection limit.The functional sensitivities of HBsAg and HBsAb were 0.025 IU/mL and 0.625 mIU/mL,respectively,and the carryover rates of both HBsAg and HBsAb was 0.The results of HBsAg and HBsAb in healthy subjects fell within the reference interval.The linear correlation equations for detecting HBsAg and HBsAb with the Abbott Alinity i and Architect i2000 immunoassay analyzers had the correlation coefficients r2 being 0.9982 and 0.9939 and the slopes a being 0.9568 and 1.0355,respectively.The results by the Alinity i immunoassay analyzer were consistent with the expected ones when used to test the EQA sample of the national center for clinical laboratories.Conclusion The Abbott Alinity i immunoassay analyzer has its stability,repeatability and precision meet clinical application requirements when used to detect HBsAg and HBsAb.