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目的:对比研究国产抗-HCV ELISA间接法和双抗原夹心法试剂的检测效能,探讨血站抗-HCV检测模式。方法:选择1种双抗原夹心法酶联免疫试剂、2种间接法酶联免疫试剂分别检测34 593名无偿献血者血样,采用重组免疫印迹试验(RIBA)对其中有反应性的44份标本进行确认,并用BBI血清盘对这2种检测试剂进行考核评价。结果:科华、新创和万泰3个厂家的抗-HCV有反应性及灰区标本经RIBA实验确证后,假阳性率分别为31%、63%、13%。万泰双抗原夹心法与间接法相比,增加了反应强度、降低了假阳性率且缩短了窗口期。结论:为确保血液质量,血筛实验室应选择灵敏度和特异性双优的试剂,采用间接和双抗原夹心2种不同的ELISA试剂检测HCV抗体优于2种间接ELISA试剂,不仅提高抗-HCV有反应性标本的检出率,而且减少血液因假阳性造成的浪费。
OBJECTIVE: To compare the detection efficacy of domestic anti-HCV ELISA indirect ELISA and double antigen sandwich assay, and explore the anti-HCV detection mode of blood test. Methods: One kind of double antigen sandwich enzyme immunoassay reagent and two indirect ELISA reagents were used to detect the blood samples of 34 593 unpaid blood donors. Reactive 44 samples were detected by RIBA Confirmed, and with BBI serum disk test evaluation of these two reagents. Results: The false-positive rates of anti-HCV-responsive and gray-zone samples of Kehua, Xinchuang and Wantei were 31%, 63% and 13%, respectively. Vantage double antigen sandwich method compared with the indirect method, increasing the reaction intensity, reducing the false positive rate and shorten the window period. Conclusion: In order to ensure the quality of blood, blood serum screening laboratories should choose double superior reagents of sensitivity and specificity. The detection of HCV antibodies by two kinds of indirect and double antigen sandwich ELISA is better than two kinds of indirect ELISA reagents, which not only improves anti-HCV There is a detectable rate of reactive specimens, but also to reduce blood waste caused by false positives.