摘要
目的 建立献血者血液混合核酸检测方法 ,调查北京现有检测体系下血液的残余风险度 ,评估核酸检测 (NAT)的必要性和可行性。方法 用世界卫生组织标准品对国产丙型肝炎病毒(HCV)和人免疫缺陷病毒 (HIV)荧光 聚合酶链反应核酸扩增检测试剂进行灵敏度、重复性和精密度试验 ;对 2 0 0 2年 2～ 10月 34373份常规血清学检测 (ALT、HBsAg、抗 HCV、抗 HIV、梅毒抗体 )合格的献血者血样进行HCVRNA和HIV 1RNA核酸扩增分析。采取 2 4人份混合血样测定 ,超离心浓缩病毒 ,Roche核酸提取柱提取病毒核酸。结果 扩增系统能 10 0 %检出 5 0IU/mlHCV及 5 0IU/mlHIV 1标准品核酸 (n =16 ) ;常规血清学检测合格的献血者血液中 ,没有检出HCV或HIVNAT阳性。结论 该核酸检测体系适用于献血者血液病毒筛查 ;北京市血液的病毒安全性已有相当高的保障。为更准确地评估NAT检测项目的可行性和必要性 ,检测标本量尚待增加。
Objective To establish the method of nucleic acid testing(NAT) for transfusion-transmitted viruses of blood donors, to study the feasibility/efficacy of NAT and to estimate the current residual risk of transfusion transmitted HIV and HCV in BeijingMethods The sensitivity, reproducibility and robustness of a domestic fluorescence PCR kits for HCV RNA and HIV-1 RNA(PJ Biotech Co, Shenzhen, China) were assayed using the WHO international standards 34 373 plasma samples from seronegtive donors (with normal level of ALT, and negative results in HBsAg, anti-HCV, anti-HIV, and Syphilis screening, collected during Feb-Oct2002) were tested for HCV and HIV-1 NAT Pools of 24 donor samples were used for NAT testing Viruses were concentrated by centrifugation and the viral RNA extraction was done using the High Pure Viral Nucleic Acid Kit (Roche, Mannheim, Germany)ResultsThe amplification system can 100% detect 50 IU/ml (n=16) HCV RNA and 50 IU/ml (n=16) HIV-1 RNA No positive HCV RNA or HIV RNA was detected in 34 373 sero-negative donorsConclusions The limited data indicate that the viral safety of blood for transfusion in Beijing is good, although the relative small sample size may not have allowed to detect the window period donors
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2004年第9期596-599,共4页
Chinese Journal of Laboratory Medicine
基金
北京市卫生局专项基金资助项目 (2 0 0 1)
