全自动多重检测试剂同时检测HBV DNA、HCV RNA和HIV-1 RNA  

Automated multiplex assay system for simultaneous detection of hepatitis B virus, hepatitis C virus and human immunodeficiency virus type 1

作　　者：尚桂芳[1] 杨立新[1] 王良华[1] 周一炎[1] 叶贤林[1] 

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《中国现代医学杂志》2005年第6期828-831,共4页China Journal of Modern Medicine

摘　　要：目的寻找一种有效实用的全自动多重检测试剂同时检测HBVDNA,HCVRNA和HIV-1RNA系统MPLC-COBAS。方法笔者采用ACROMETRIX公司的NACTMHBVDNA,HCVRNA及HIV-1RNA核酸对照品,卫生部临床检验中心的HBVDNA,HCVRNA质控对照品,检测该系统的灵敏度;同时采用我中心酶免法(ELISA)初筛检结果阳性,经中和实验确认HBsAg阳性标本10份,经RIBA确认抗-HCV阳性标本3份,经WesternBlot确认抗-HIV阳性标本3份,检测该系统的阳性符合率;检测大量临床ELISA筛检结果为阴性的标本来检测其特异性,并且每次实验设立内对照,阴阳性对照以进行临床标本检测。结果该系统的检测灵敏度(95%可信限)为HBV病毒为24-60IU/mL,HCV病毒为78-125IU/mL,HIV-1RNA病毒为45-67IU/mL,阳性符合率为100%,假阳性率为0.13%。结论全自动多重检测试剂同时检测HBVDNA,HCVRNA和HIV-1RNA系统MPLC-COBAS用于检测临床标本是有效实用的,可进一步加大临床标本检测数量,将该系统更好地用于酶联阴性结果的大规模筛查。To find one automated multiplex system MagNA Pure LC (MPLC-COBAS) for simultaneous detection of hepatitis B virus DNA(HBV DNA), hepatitis C virus(HCV RNA) and human immunodeficiency virus type 1 RNA(HIV-1 RNA). Using this system, we detect the standard nucleic acid from America Acrometrix and China Clinical Laboratory Center to find its sensitivity, detect 10 neutralized test determined HBsAg positive specimen, 3 RIBA determined anti-HCV positive specimen and 3 Western Blot determined anti-HIV positive specimen to find its positive confirmatory rate with ELISA, detect clinical specimen to find its false-positive rate. The sensitivity for HBV DNA, HCV RNA, HIV-1 RNA respectively is 24~60 IU/mL,78~125 IU/mL and 45~67 IU/mL. The positive confirmatory rate is 100%. The false positive rate is 0.13%. [Conclusion] MPLC-COBAS system is robust, sensitive, with a low false-positive rate. We can use it more for routine clinical detection.

关 键 词：多重检测试剂(MPX) MPLC-COBAS系统 病毒核酸检测(NAT) 

分 类 号：R446[医药卫生—诊断学]