COBAS S201核酸检测系统在献血者血液筛查中的应用

Use of COBAS $201 nucleic acid detection system in screening blood donors

目的 采用罗氏COBAS S201核酸检测系统,调查东莞市现行血液筛查系统的残余风险,以评估开展核酸检测（nucleic acid amplification technique,NAT）的必要性和可行性.方法 对2008年7月31日至2009年3月31日期间经ELISA检测阴性的40 018份献血者血液样本,采用罗氏COBAS S201检测系统进行HBV DNA,HCV RNA,HIV RNA检测.COBAS S201检测为阳性的献血者样本,分别采用COBAS Ampliprep/Taqman平台做核酸定量检测和罗氏ECL电化学发光检测系统作乙肝＂两对半＂实验,以帮助分析判定样本的感染状态.结果 发现31例核酸反应性样本,阳性率为0.77‰,其中有17例为HBV核酸反应性,残余风险为1/2354～1/1291,COBAS S201核酸检测系统的临床特异性为99.97%.结论 现行的血液筛查策略为两遍ELISA检测,但仍然存在输血传播疾病的风险.COBAS S201系统操作安全简便,包含罗氏专利技术的防污染技术,可确保检测结果准确可靠,适合于对献血者血液常规筛查.

Objective To investigate the residual risk in the current blood screening system in Dongguan City by Roche COBAS S201 nucleic acid detection system, in order to assess the necessity and feasibility of nucleic acid amplification technique （NAT）. Methods 40 018 ELISA-negative samples were detected for HBV DNA, HCV RNA as well as HIV RNA by Roche COBAS S201 detection system from July 31,2008 to March 31, 2009. Positive samples were under quantitative detection of nucleic acid by COBAS Ampliprep/Taqman platform as well as ＂two pairs of semi ＂-experiments of hepatitis B by Roche ECL electrochemiluminescence detection system, aiming at helping to analyze the infection status of samples.Results 31 NAT-reactive samples were found, and the positive rate was 0.77‰. 17 of 31 samples were HBV DNA-reactive, and the residual risk was 1/2354-1/1291. The clinical specificity of COBAS S201 nucleic acid detection system was 99.97%. Conclusions The current blood screening strategy is that the samples are under twice ELISA detections, but the risk of transfusion-transmitted diseases still lies in it.COBAS S201 nucleic acid detection system, safe and easily operative, including Roche＇s patented antipollution technology, can ensure the accuracy and reliability for test results and is suitable for the routine use in blood screening.