TRFIA法检测HBV表面抗原最佳临界值的探讨

Exploring the Optimum Critical Value of HBV Surface Antigen Detected by TRFIA

目的:探讨时间分辨荧光免疫分析法检测乙型肝炎病毒(HBV)表面抗原诊断阳性的最佳临界值。方法:选取某三甲医院住院或体检的170例经TRFIA法定量检测阳性的血清或血浆标本和40例接近临界值(阴性)标本(0.03-0.05IU/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,确定最佳临界值。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,有统计学差异(P<0.05),两试验结果一致性的Kappa值为0.673。TRFIA法检测HBV表面抗原诊断阳性的最佳临界值为0.080IU/mL,此时,TRFIA法检测结果与确证试验结果一致性的Kappa值为0.832。结论:不同实验室应根据自身情况,制定适合本实验室最佳临界值,能一定程度上减少漏诊率和误诊率。

Objective: To explore the optimum critical value of TRFIA for detection of hepatitis B virus (HBV) surface antigen. Methods: 170 serum or plasma samples detected positive of HBV surface antigen by TRFIA and 40 negative specimens but close to the critical value(0.03~0.05IU/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. Determined the optimum critical value by drawing the ROC curve through SPSS19.0. Results: Under the given critical value specified by the reagent,there was statistical difference between the results of TRFIA and confirmation(P<0.05). While the consistency of two test results was the Kappa value 0.673. However, the optimum critical value of TRFIA for detection of HBV surface antigen positive diagnosis was 0.080IU/mL. At that time, the Kappa value of consistency between the results of TRFIA and the results of confirmation was 0.832. Conclusion: According to own laboratory conditions, different laboratories should establish the optimum threshold suitable for the laboratory. To some extent, it can reduce the rate of missed diagnosis and misdiagnosis rate.