甲胎蛋白定量测定试剂盒的临床应用

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...

Clinical evaluation of ELISA for determination of AFP

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.