时间分辨荧光免疫分析法检测游离F-βHCG的方法学评价

Evaluation of the methodology of the time-resolved fluoroimmunoassay in F-βHCG measurements

目的对时间分辨荧光免疫分析法(TRFIA)定量检测F-βHCG的各种性能指标进行方法学评价,验证其临床适用性。方法通过灵敏度、批内和批间精密度、标准曲线稳定性参数等指标评价TRFIA检测F-βHCG的性能,同时通过回收试验分析其准确度。结果 F-βHCG的最小测定值为0.09ng/ml,低、中、高3种质控品批内和批间变异系数均小于10%,标准曲线稳定性参数各变异系数小于5%,回收试验结果在97%～104.7%之间。结论 TRFIA法检测F-βHCG具有准确性好、灵敏度高、特异性强、能自动化分析等优点,能充分满足临床检测的需求。

Objective The methodology of time-resolved fluoroimmunoassay（TRFIA）that detected F-βHCG was evaluated by quantitative assay.Methods The functional sensitivity of free β-HCG,imprecision of extra-assay and intra-assay were tested with free β-HCG assay.The recovery tests were performed by quantitative assay with free β-HCG assay.Results The functional sensitivity of the free β-HCG assay was 0.09ng/ml.The extra-assay cv% and the intra-assay cv% were smaller than 10%,and approved that the stability parameter various coefficient of variation was also smaller than 5%.The recycling experiment result was 97%～104.7%.Conclusion It is concluded that the methodology of time-resolved fluoroimmunoassay offers many benefits in sensitivity,precision,accuracy,reliability and practicability.