传染病血清标志检测指标的发展与应用精编PPT课件.ppt

乙肝表面抗体是乙肝的五项血清学指标中唯一的具备WHO参考物质可以进行标准化的项目。因为通常表面抗体的浓度可以评估机体保护HBv感染的能力，所以最新的检测方式都是将Anti-HBs进行定量化检测。 WHO抗HBs标准品针对的抗原主要是adw，相对来说对ayw和adr的结合能力降低，可使抗HBs定量测定结果偏低。 血清中抗体的复杂性。 感染的患者的体内会存在着抗a,d or y等抗原决定簇的特异抗体，接种的个体产生的抗体的构成依赖于疫苗的成份 对不同抗HBs检测试剂的比较研究表明，从不同试剂得到的抗HBs浓度有很大不同 。 各家试剂中采用的表面抗原的材料（来源于血浆或者基因工程），抗原的亚型以及处理程序等都很大程度的影响着Anti-HBs的结果 一个可靠的抗HBs测定方法应能检测针对HBsAg的各种抗体，包括HBsAg的a和各种亚型特异决定簇。 The figure displays the sensitivity of Elecsys? HBeAg in comparison to the MEIA-test (Abbott, IMx) in serial dilutions of the PEI-reference material in human HBV-negative serum. The Elecsys? test shows an excellent sensitivity of 0.19 PEI U/mL while it was 1.2 PEI U/mL for the IMx HBe 2. Another comparison of Elecsys? HBeAg to the Abbott Axsym HBe indicated a comparable analytical sensi-tivity for both assays. The claimed analytical sensitivity of the Elecsys? HBeAg test is ≤ 0.3 PEI U/mL. PEI = Paul- Ehrlich- Institut, German registration authority Serial dilution tests also indicated linearity of the tests results up to 100 PEI U/mL for Elecsys? HBeAg. Elecsys? HBeAg measurement of serial dilutions of recombinant HBeAg, in HBeAg-negative human serum. Concentration were determined by referencing against a standard dilution series. No false negatives due to High-Dose Hook effect was observed with Elecsys? HBeAg up to 1000 PEI U/mL. Linearity The Elecsys? HBeAg test yields a linear relationship between the cut-off index (COI) determined and the HBeAg concentration over a broad concentration range. This has been demonstrated using serial dilutions of recombinant HBeAg and HBeAg-positive human sera. A semi-quantitative determination of the HBeAg concentration in a sample can be performed due to the linear nature of the curve for concentrations of 0.3 to 100 PEI U/mL (COI of 1.5 to 400). 对于治疗后的0－4周，HBeAg水平的下降（50％)的预示意义是独立的。 预示意义要远超HBV DNA,HBV DNA快速下降(90%)也有可能最终不能发生HBeAg转阴。 基线值越低，血清转换几率越高。 治疗后24周的HBeAg 水平与是否产生药物应答有相关。 HBeAg 10PEIU/ml(=40)， 72周时有55％的转阴率 HBeAg 100PEIU/ml(=400), 72周时，只有5%的转阴率 在治疗中HBV