献血者HBV、HCV、HIV的单人份核酸检测  

Individual Donation Nucleic Acid Test Using Procleix TIGRIS System

作　　者：蒋昵真[1] 黄成垠[1] 肖建宇[1] 史广耀[1] 唐荣才[1] 魏鹏[1] 

机构地区：[1]江苏省血液中心,南京210042

出　　处：《临床输血与检验》2010年第3期208-210,共3页Journal of Clinical Transfusion and Laboratory Medicine

摘　　要：目的应用Procleix ULTRIO Assay和Procleix TIGRIS System进行献血者单人份病毒核酸检测(ID-NAT),以了解ELISA法筛查的HBV、HCV、HIV漏检率,同时对ID-NAT和汇集NAT(MP-NAT)模式进行比较。方法在进行2次ELISA法筛查的同时,应用ULTRIO试剂在TIGRIS系统上行ID-NAT检测,对有活性的标本再分别进行HBV、HCV、HIV的鉴别测定,对ID-NAT阳性标本再进行8个(MP-8-NAT)和16个(MP-16-NAT)样品的模拟混样检测。结果在10064名无偿献血者中,共检出10例ELISA法阴性、ID-NAT阳性标本,ELISA法筛查漏检率为0.99‰,该10例标本经鉴别实验确定为HBV DNA阳性;共检出28例ELISA法阳性、ID-NAT阳性标本,其中HCV6例、HBV22例。将28例ELISA法阳性、ID-NAT阳性及10例ELISA法阴性、ID-NAT阳性标本进行8个、16个样品模拟汇集,结果 MP-8-NAT、MP-16-NAT的阳性检出率分别下降为78.6%、75.0%和30.0%、20.0%。结论 2次ELISA法血清学筛查模式存在较高的HBV漏检;ID-NAT的灵敏度高于MP-NAT,对于ELISA法阴性、ID-NAT阳性标本,MP-NAT存在很高的漏检率。Objective Nucleic acid testing（NAT）by Procleix ULTRIO Assay and ProcleixTIGRIS System was used to screen blood donations for HBV,HCV,HIV,so as to get the leakage of serologic screening.Individual donation NAT（ID-NAT）format and minipools NAT（MP-NAT）format were compared as well.Methods ID-NAT by Procleix ULTRIO Assay and twice ELISAs were simultaneously proceeded.ULTRIOpositive specimens were respectively discriminated and experienced simulative minipools of 8 and 16 NAT（MP-8-NAT and MP-16-NAT）.Results Among 10 064 specimens,10 were found ELISA negative while ID-NAT positive and identified as HBV DNA positive carriers.The leakage of HBV serologic screening was up to 0.99‰.28 both ELISA and ID-NAT positive specimens were also found,among which 6 were HCV and 22 were HBV carriers.These 28 both ELISA and ID-NAT positive specimens and 10 ELISA negative while ID-NAT positive specimens were diluted to simulate minipools of 8 and 16 NAT.Their positive rates of MP-8-NAT and MP-16-NAT compared to ID-NAT were respectively 78.6%,75.0% and 30.0%,20.0%.Conclusion Twice ELISA-format had a high leakage of HBV.ID-NAT shows higher sensitivity than MP-NAT,especially for ELISA negative while ID-NAT positive specimens.

关 键 词：核酸检测 单人份 HBV HCV HIV 

分 类 号：R392.11[医药卫生—免疫学]