Sensitivity
乙肝血清学标记物检测面临的挑战低浓度HBsAg，检测灵敏度不够HBsAg抗原表位变异，造成不能检出“HBsAg阴“漏检”性”隐性HBV感染
低浓度HBsAg，检测 灵敏度不够 ——“漏检” HBsAg抗原表位变异，造 成不能检出 / “HBsAg阴 性” ——隐匿性HBV感染 乙肝血清学标记物检测面临的挑战
全球70种试剂分析灵敏度差异巨大（0.02-4.5Iu/ml)ElecsysHBsAg灵敏度：0.023Iu/mlIU/ml!451AICBS#220A/adw23·PEIHBsAgad3AAA40-44403-5HBsAgRapid tests3-0ssHBsAgAEIAtests2.5A20A1.5?A1-0-A050000soon2oos304020506070010HBsAg test kits?Scheiblauer.Hetal.VoxSang.2010,98:403-414
Scheiblauer.H et al.Vox Sang .2010,98:403-414. 全球70种试剂分析灵敏度差异巨大(0.02-4.5Iu/ml) Elecsys HBsAg 灵敏度：0.023 Iu/ml
不同试剂之间HBsAg灵敏度相差显著TABLEIII.Analytical Sensitivities of HBsAgAssaysRelativeto the2nd InternationalHBsAgStandard(NIBSCCode00/588)AnalyticalsensitivitiesMeasurementwithConversionto2ndMeasurementwithPEIHBsAgAd1000WHO HBsAg2nd WHO HBsAgHBsAgAssay(PEIU/ml)(IU/ml)(IU/ml)PRISMHBsAg0.0090.0210.0300.0090.0210.014EnzygnostHBsAg5.00.03MonolisaAgHBsPlus Ultra0.0130.044ElecsysHBsAg0.0100.0330·0230.0180.033MurexHBsAgVersion30.0420.025ETI-MAK-4(methodA)0.0580.0240.050ARCHITECTHBsAg0.0160.0370.0140.0330.049Liaison HBsAgAdvia Centaur HBsAg0.0100.0230.0230.070n.d.VitrosHBsAg0.030n.d.IMxHBsAg(V2-22)0.0090.0210.0450.104Immulite2000HBsAg0.1050.0180.0420.045AxSYMHBsAg(V2)ORTHOHBsAgELISATS30.0170.040n.d.0.0350.081n.d.CobasCoreHBsAgIIEIAn.d.0.0420.098Genedia HBsAg3.00.1120.111BioelisaHBsAg color0.0480.0380.088n.d.HepanostikaHBsAgUni-Form II 1.2(90agitation)"Assaycut-off:0.05IU/mln.d.notdetermined.JMedVirol79:S59-S64(2007)
不同试剂之间HBsAg灵敏度相差显著 J Med Virol 79:S59–S64 (2007)
不同试剂之间HBsAg灵敏度相差显著Panel numberTotal daysMeantimetoconsistentfirstpositiveresult(days)sincefirst(no. samplesElecsys HBsAgElecsys HBsAgElecsys HBsAgblood sampleperdonation)II vs. ArchitectII vs. AxSYMII vs. ChineseHBsAg assayHBsAg assayaMTP ELISA5421 vs.2218 vs.1619 vs.47BCP6281(n=12)11594 vs. 10294 vs.9894 vs. >115BCP6272(n=26)3620 vs.2020vs.35PHM908(n =8)56PHM915(n=13)16vs.2417 vs.>564226 vs.2626 vs.35PHM920 (n = 6)178 vs. 14PHM903(n=4)299vs.16PHM929 (n=9)840 vs.4PHM934(n=6)检出阳性样品时间ElecsysHBsAgI比ChineseMTPELISA早22天。在各种方法中，ElecsysHBsAgⅡ是最早检测出HBsAg的方法。MedMicrobiollmmunol(2009)198:263-269
不同试剂之间HBsAg灵敏度相差显著 Med Microbiol Immunol (2009) 198:263–269 检出阳性样品时间Elecsys HBsAg II比Chinese MTP ELISA早22天。在各种方法中，Elecsys HBsAg II是最早检测出HBsAg的方法