中华实验和临床病毒学杂志
中華實驗和臨床病毒學雜誌
중화실험화림상병독학잡지
CHINESE JOURNAL OF EXPERIMENTAL AND CLINICAL VIROLOGY
2010年
4期
311-313
,共3页
车嘉琳%黄志森%王德文%梁兵%师玲玲%许惠芯%朱毅瑜
車嘉琳%黃誌森%王德文%樑兵%師玲玲%許惠芯%硃毅瑜
차가림%황지삼%왕덕문%량병%사령령%허혜심%주의유
供血者%肝炎病毒,乙型%肝炎,丙型%HIV%核酸扩增技术
供血者%肝炎病毒,乙型%肝炎,丙型%HIV%覈痠擴增技術
공혈자%간염병독,을형%간염,병형%HIV%핵산확증기술
Blood donors%Hepatitis B virus%Hepatitis C%HIV%Nucleic acid amplification techniques
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.
目的 採用囉氏COBAS S201覈痠檢測繫統,調查東莞市現行血液篩查繫統的殘餘風險,以評估開展覈痠檢測(nucleic acid amplification technique,NAT)的必要性和可行性.方法 對2008年7月31日至2009年3月31日期間經ELISA檢測陰性的40 018份獻血者血液樣本,採用囉氏COBAS S201檢測繫統進行HBV DNA,HCV RNA,HIV RNA檢測.COBAS S201檢測為暘性的獻血者樣本,分彆採用COBAS Ampliprep/Taqman平檯做覈痠定量檢測和囉氏ECL電化學髮光檢測繫統作乙肝"兩對半"實驗,以幫助分析判定樣本的感染狀態.結果 髮現31例覈痠反應性樣本,暘性率為0.77‰,其中有17例為HBV覈痠反應性,殘餘風險為1/2354～1/1291,COBAS S201覈痠檢測繫統的臨床特異性為99.97%.結論 現行的血液篩查策略為兩遍ELISA檢測,但仍然存在輸血傳播疾病的風險.COBAS S201繫統操作安全簡便,包含囉氏專利技術的防汙染技術,可確保檢測結果準確可靠,適閤于對獻血者血液常規篩查.
목적 채용라씨COBAS S201핵산검측계통,조사동완시현행혈액사사계통적잔여풍험,이평고개전핵산검측(nucleic acid amplification technique,NAT)적필요성화가행성.방법 대2008년7월31일지2009년3월31일기간경ELISA검측음성적40 018빈헌혈자혈액양본,채용라씨COBAS S201검측계통진행HBV DNA,HCV RNA,HIV RNA검측.COBAS S201검측위양성적헌혈자양본,분별채용COBAS Ampliprep/Taqman평태주핵산정량검측화라씨ECL전화학발광검측계통작을간"량대반"실험,이방조분석판정양본적감염상태.결과 발현31례핵산반응성양본,양성솔위0.77‰,기중유17례위HBV핵산반응성,잔여풍험위1/2354～1/1291,COBAS S201핵산검측계통적림상특이성위99.97%.결론 현행적혈액사사책략위량편ELISA검측,단잉연존재수혈전파질병적풍험.COBAS S201계통조작안전간편,포함라씨전리기술적방오염기술,가학보검측결과준학가고,괄합우대헌혈자혈액상규사사.
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.
