TRFIA法检测HBV表面抗原最佳临界值及灰区探讨

Exploring the optimum critical value and grey zone of HBV surface antigen detected by TRFIA

目的探讨时间分辨荧光免疫试验(TRFIA)检测乙型肝炎病毒(HBV)表面抗原诊断阳性的最佳临界值及其灰区。方法选取某三甲医院住院或体检的150例经TRFIA法定量检测阳性的血清或血浆标本和30例接近临界值(阴性)标本(0.03~0.05 IU/mL),采用化学发光微粒子免疫分析法确认其阴、阳性。绘制ROC曲线,判断最佳临界值,进一步探讨其灰区。结果在试剂说明给定的临界值下,TRFIA法检测结果与确证试验结果比较,差异有统计学意义(P<0.05),两试验结果一致性的Kappa值为0.690。TRFIA法检测HBV表面抗原诊断阳性的最佳临界值为0.074 IU/mL,此时,TRFIA法检测结果与确证试验结果一致性的Kappa值为0.814,其灰区范围为0.05~0.274 IU/mL。结论不同实验室应根据自身实验室的情况,制定适合本实验室最佳临界值和灰区,为临床诊断提供可靠的依据。

Objective To explore the optimum critical value and grey zone of time resolved fluorescence immunoassay(TRFIA)for detection of hepatitis B virus(HBV)surface antigen.Methods 150 serum or plasma samples detected positive of HBV surface antigen by TRFIA and 30 negative specimens but close to the critical value(0.03-0.05 IU/mL)from patients or people who did physical examination in a top-grade hospital were chosen and chemiluminescence particle immunoassay was used to confirm them positive or negative.Drawing the ROC curve through SPSS19.0 to determine the optimum critical value and compute grey zone.Results Under the given critical value specified by the reagent,There was statistical difference between the results of TRFIA and the results of confirmation(P<0.05).While two test results of consistency of the Kappa value was 0.690.However,The optimum critical value of TRFIA for detection of HBV surface antigen positive diagnosis was 0.074 IU/mL.At this time,the Kappa value of consistency between the results of TRFIA and the results of confirmation is 0.814.And The grey zone ranges from 0.05 to 0.274 IU/mL.Conclusion According to their own laboratory conditions,different laboratories should establish the optimum threshold and grey zone suitable for the laboratory.In order to provide reliable basis for clinical diagnosis.