【摘要】 目的比较全自动酶免后处理分析系统与手工操作法的差异。方法 2013年于湖北省中医院随机收集的人类免疫缺陷病毒抗体(抗-HIV)阴性血清标本及梅毒螺旋体抗体(抗-TP)阴性血清标本各240份。1套珠海丽珠公司抗-HIV血清盘和1套北京康彻斯坦公司抗-HIV国家标准物质,以及1套珠海丽珠公司抗-TP血清盘和1套北京康彻斯坦公司抗-TP国家标准物质分别使用BEP-3酶免后处理与手工操作平行试验,测定其吸光度值,计算两种方法的变异系数、符合率、特异度,并使用SPSS19.0软件对两种方法相关数据进行比较。结果 0.5NCU/mL抗-HIV标准物质用手工操作和BEP-3酶免后处理试验CV分别为12.5%、7.4%,6mIU/mL抗-TP标准物质用手工操作和BEP-3酶免后处理试验CV分别为13.8%、6.5%,EP-3酶免后处理的CV明显低于手工操作法CV,比较差异有统计学意义(P<0.05);两种方法对抗-HIV、抗-TP血清盘阳性、阴性参考品检测符合率100.0%,两种方法对抗-HIV、抗-TP系列稀释参考品的最低检出率分别为66.7%、77.5%。两种方法对240份阴性标本的特异度均为100.0%。结论 BEP-3酶免后处理与手工操作相比,重复性更好,符合率、特异度一致,可以替代手工操作用于临床常规标本检测。更多还原

【Abstract】 Objective To compare the difference between automatic enzyme-linked immunosorbent assay(ELISA)analysis system and manual processing method.Methods Negative anti-HIV serum samples(240samples)and negative anti-TP serum samples(240samples)were collected randomly in Hubei Provincial Hospital of TCM in 2013.A set of anti-HIV serum plate produced in Zhuhai Lizhu company,a set of anti-HIV standard material produced in Beijing Kangchesitan company,a set of anti-TP serum plate produced in Zhuhai Lizhu Company,and a set of anti-TP standard material produced in Beijing Kangchesitan Company were tested by the BEP-3ELISA analysis system and manual processing method.The absorbance values were measured,and calculated the coefficient of variation(CV)of the two methods,coincidence rate,specificity.Software SPSS 19.0was used to compare the differences of the two methods.Results The detection CVof anti-HIV standard material and anti-TP standard material by manual processing method and BEP-3ELISA analysis system were 12.5%,7.4%,and 13.8%,6.5%.The CVof BEP-3ELISA analysis system was significant lower than that of manual processing method(P<0.05).The coincidence rate of the two methods on the positive and negative references of anti-HIV serum plate and anti-TP serum plate were all 100.0%,the lowest detection of the anti-HIV and anti-TP serial dilution products were all 66.7%,77.5%respectively.The specificity of the two methods on the 240 negative samples were 100.0%Conclusion Compared with manual operation,automatic ELISA analysis system has better repeatability,while has same coincidence rate and specificity so the BEP-3ELISA analysis system could replace manual handling for routine clinical sample testing.更多还原