TrFIA乙肝病毒PreS1抗原的应用研究

目的:乙型肝炎病毒PreS1抗原时间分辨荧光免疫分析(TrFIA)的应用.方法:收集120例HBVDNA拷贝数＞103的乙型肝炎患者血清标本,同时应用TrFIA和酶联免疫吸附法(ELISA)对样本中PreS1抗原进行检测.选择荧光值较高的一例PreS1抗原阳性血清标本,倍比稀释至1:16384倍,用TrFIA试剂与ELISA定性试剂盒同时进行PreS1抗原的检测.结果:有9例标本ELISA结果为阴性,而用TrFIA可检测到PreS1抗原,χ2=7.1,P＜0.05,TrFIA方法灵敏度高于ELISA方法.一例PreS1抗原阳性血清标本ELISA在1:2048倍时结果为阴性,而TrFIA在1:8192倍时仍可检出PreS1抗原.TrFIA方法高、中、低三个浓度批内CV分别为3.57%、3.71%、6.74%;批间CV分别为3.54%、4.16%、8.52%均优于ELISA方法.50份正常体检者血清标本(乙肝标志物均阴性)用TrFIA试剂进行PreS1抗原的检测,结果均阴性,特异性100%.结论:TrFIA与ELISA相比,精密度和灵敏度有较大提高.

Clinical Application of TrFIA for HBV pre -S1 Antigen Detection

Objective To compare the clinical applicability of time-resolved fluro-immuno-assay (TrFIA) with that of ELISA for detection of HBV pre-S1 antigen. Methods HBV pre-S1 antigen was detected in 120 serum specimens from hepatitis B patients (with HBV DNA copies>103) with both TrFIA and ELISA. Results HBV pre-S1 antigen was positive in 108 of the 120 specimens with TrFIA and only in 99/120 with ELISA, showing higher sensitivity with TrFIA (P<0.05). Take a sample case: TrFIA was positive for pre-S1 antigen at 1:8192 dilution while ELISA was already negative at 1:2048 dilution. The intra and inter-CV with TrFIA were also better than the corresponding values with ELISA. No false positive result was shown in 50 normal specimens with TrFIA. Conclusion For clinical use, TrFIA is superior to ELISA for HBV pre-S1 antigen detection.