乳胶增强免疫比浊法与电化学发光法检测降钙素原的对比分析

Contrast Analysis of Detecting Procalcitonin by Latex EnhancedI mmunoturbidimetry and Electrochemiluminescence

目的:探讨乳胶增强免疫比浊法与电化学发光法检测降钙素原结果的可比性。方法:依照美国临床实验室标准化协会指南比对标准文件EP9-A2,以电化学发光-双抗体夹心法为比较方法,以乳胶增强免疫比浊法为试验方法,采用患者血清样本检测降钙素原含量,通过检测数据比对分析,对两种检测方法之间的偏倚进行评估。结果:两种方法检测降钙素原(PCT)在线性范围内的结果,直线回归方程为Y=0.037+0.992 15X,相关性良好,r=0.99092,在选定PCT医学决定水平0.5 ng/ml、2 ng/ml、10 ng/ml以比较方法为参考方法计算两种方法检测值的阳性符合率为95%、96.25%、95%,经χ~2检验表明差异无统计学意义(P>0.05)。结论:胶乳增强免疫比浊法与电化学发光法均能有效检测降钙素原且相关性良好,均能满足临床需要,适合临床实验室推广使用。

Objective To investigate the comparability of the results of detecting procalcitonin by latex enhanced immunoturbidimetric assay and electrochemiluminescence assay.Method According to the standard of American Society of Clinical Laboratory Standards（EP9-A2）,the electrochemiluminescence assay was used as the reference method,and latex enhanced immunoturbidimetric assay was used as the test method.The serum samples were used to detect procalcitonin.The bias between the two test assays was evaluated by data comparison analysis.Results The linear regression equation of theprocalcitonin（PCT）measured by these two methods was Y=0.037＋0.992 15 X with good correlation,while the correlation index r=0.99092.The biaswas acceptable at PCT medical decision level.Compared with the reference method,we selected PCT medical decision level of 0.5 ng/ml、2 ng/ml、10 ng/ml and found that the positive coincidence rate of the values measured by the two methods was 95%、96.25%、95%.The chi-square test showed that the difference was not statistically significant（P〉0.05）.Conclusion Latex enhanced immunoturbidimetric assay and electrochemiluminescence assay both could effectively detect procalcitonin,and the correlation is good,which can meet the clinical needs for clinical laboratory use.