摘要
目的:通过新试剂(酶联免疫法)与已上市的试剂1(酶联免疫法)和试剂2(化学发光法)定量测定甲胎蛋白的比较,重点评价新试剂(酶联免疫法)测定甲胎蛋白的临床应用价值。方法:将发光法测定的AFP高、中、低值300份血清分别用上述三种方法进行检测,进行回归分析及相关分析。将低、中、高值质控品分别用上述三种方法每天测定一次,连续测20天,计算比较批内变异系数和批间变异系数。将同一份高值混合血清进行8倍比稀释后分别用上述三种方法检测进行线性分析。结果:新试剂与试剂2检测结果高度相关,R值为0.995;直线回归方程Y=1.027 x-2.205;新试剂与试剂2符合率为94.33%,新试剂与试剂1合率98.67%;新试剂测质控血清低值:批内CV6.87%,批间CV5.21%,中值:批内CV5.54%,批间CV5.21%,高值:批内CV3.54%,批间CV3.01%。试剂2测质控血清低值:批内CV6.55%,批间CV4.62%,中值:批内CV4.41%,批间CV4.62%,高值:批内CV3.05%,批间CV3.23%。试剂1测质控血清低值:批内CV4.26%,批间CV4.99%,中值:批内CV2.52%,批间CV1.40%,高值:批内CV1.01%,批间CV1.18%。两种方法在各自的线性范围内线性良好。结论:新试剂甲胎蛋白定量测定试剂盒(酶联免疫法)与已上市的试剂1(酶联免疫法)及试剂2(化学发光法)高度相关,可供临床使用。
Objective Through comparison of three kinds of methods such as the new agent(enzyme-linked immunosorbent method),agent1(enzyme-linked immunosorbent method) and agent2(chemiluminescence immunoassay,clia) to evaluate the clinical application value of e new agent(enzyme-linked immunosorbent method).Methods With these three methods to test the 300 serum of high,medium and low serum,then do regression analysis and correlation analysis;with the three methods to test the low,medium and high quality products once every day for 20 days,Calculation and comparison within the batch of variation coefficient and coefficient of variation between;multiple proportions the same mixed high value serum for 8 times,then test them With these three method and do Linear analysis Results the results of the new agent and agent1 are highly relevant,R=0.995;The Linear regression equation is Y = 1.027 x-2.205;the accuracy of he new agent(ELISA) and agent2(chemiluminescence immunoassay,clia) is 94.33%;the accuracy of the new agent and agent1 is 98.67%;the new agent's result of the low Qc serum : In batch is CV6.87%,batch between is CV5.21%.The medium : In batch is CV5.54%,batch between is CV5.21%.the high: In batch is CV3.54%,batch between is 3.01%.agent1's result of the low Qc serum : In batch is CV6.55%,batch between is CV4.62%.the medium : In batch is 4.41%,batch between is CV4.62%.The high: In batch is CV3.05%,batch between is CV3.23%.Agent2's result of the low Qc serum : In batch is CV4.26%,batch between is CV4.99%.The medium: In batch is 2.52%,batch between is CVCV1.40%.the high: In batch is CVCV1.01%,batch between is CV1.18%.The two method's linear relationship is Good in their Linear range.Conclusion the relevantionship of the new agent(enzyme-linked immunosorbent method),agent1(enzyme-linked immunosorbent method) and agent2(chemiluminescence immunoassay,clia) is high,so it can be applied in clinic.
出处
《湖南师范大学学报（医学版）》
2011年第1期67-71,共5页
Journal of Hunan Normal University(Medical Sciences)
关键词
甲胎蛋白
酶联免疫法
化学发光法
α fetal protein
enzyme-linked immunosorbent
chemistry
