CAJ | 학술논문

目的：了解该地区无偿献血输血残留风险，以及罗氏诊断公司第一代与第二代核酸联合检测试剂的简单比对。方法选择2013年5～7月经该站常规检测合格血液（血清学酶免检测结果均阴性）的标本采用罗氏诊断公司第一代和第二代核酸联合检测试剂在罗氏COBAS s 201操作系统进行6标本混样试验，如试验有反应性，则进行核酸鉴别试验和其他补充血清学检测。结果该次研究共检测标本9417份，筛查出8例核酸阳性，阳性率为0．85‰，经过核酸鉴别试剂检测，其中有4例标本确认为HBV核酸阳性，1例为HCV核酸阳性，其余3例为HBV阳性不确定。另外，如果以第一代试剂（参比试剂）为相对标准，第二代试剂（考核试剂）总的阳性符合率为66．67％，阴性符合率为99．98％，总符合率为99．96％。另外，试验未发现 H IV核酸阳性标本。结论核酸检测技术能有效缩短“窗口期”，能进一步提高输血安全性，同时罗氏公司第一代核酸联合检测试剂与第二代试剂总体符合情况良好，但在检测 HBV上有较小差异。
목적：료해해지구무상헌혈수혈잔류풍험，이급라씨진단공사제일대여제이대핵산연합검측시제적간단비대。방법선택2013년5～7월경해참상규검측합격혈액（혈청학매면검측결과균음성）적표본채용라씨진단공사제일대화제이대핵산연합검측시제재라씨COBAS s 201조작계통진행6표본혼양시험，여시험유반응성，칙진행핵산감별시험화기타보충혈청학검측。결과해차연구공검측표본9417빈，사사출8례핵산양성，양성솔위0．85‰，경과핵산감별시제검측，기중유4례표본학인위HBV핵산양성，1례위HCV핵산양성，기여3례위HBV양성불학정。령외，여과이제일대시제（삼비시제）위상대표준，제이대시제（고핵시제）총적양성부합솔위66．67％，음성부합솔위99．98％，총부합솔위99．96％。령외，시험미발현 H IV핵산양성표본。결론핵산검측기술능유효축단“창구기”，능진일보제고수혈안전성，동시라씨공사제일대핵산연합검측시제여제이대시제총체부합정황량호，단재검측 HBV상유교소차이。
Objective To understand the residual risk of transfusion blood donation in the native region and to conduct the sim-ple comparison of Roche diagnostic company′s first generation and second generation nucleic acid combined detection reagents . Methods The menstrual blood specimens qualified by the routine test in this center (serology test and enzyme immunodetection as-say results were negative) from May to July 2013 were selected and performed the 6-specimen mixed sample test by adopting the Roche Diagnostics company′s first-generation and second-generation nucleic acid combined detection reagents in the United Roche COBAS s 201 operating system ,if the test had the reactivity ,the nucleic acid identification tests and other complementary serologi-cal testing were performed .Results 9 417 specimens were detected ,8 cases of nucleic acid positive were screened out with the posi-tive rate of 0 .85 ‰ ,through the detection of nucleic acid identification reagents ,4 specimens were confirmed as positive for HBV nucleic acid ,1 case was positive for HCV nucleic acids and the rest 3 cases of uncertain HBV-positive .In addition ,with the first generation reagent (reference reagents) as the relative standard ,the second generation reagents (assessment reagent) had the over-all positive coincidence rate of 66 .67% ,the negative coincidence rate of 99 .98% and the total coincidence rate of 99 .96% .In addi-tion ,no HIV nucleic acid positive specimens was found by the nucleic acid test .Conclusion The nucleic acid detection technique can effectively shorten "window period",further improve the safety of blood transfusions ,at the same time the overall conformance situ-ation of the Roche′s first-generation nucleic acid combined detection reagents and the second generation combined detection reagents is good ,but there are still lesser differences in the detection of HBV .