梅里埃VIDAS免疫荧光分析仪、贝克曼DXI-800化学发光仪检测血清β-HCG、孕酮结果一致性分析

The condidtency anslysis of serum β-HCG and progesterone measured by VIDAS immunofluorescence analyzer and Backman DXI-800 chemiluminescence analyzer

目的:依据美国临床实验室标准化委员会(NCCLS)的EP9-A2文件,对本院拥有的两种不同检测系统检测β-HCG、孕酮的结果进行比对分析,探讨其是否具有可比性,为实现不同实验室检验结果互认提供实验数据依据.方法:选择贝克曼DXI-800化学发光仪所组成的检测系统作为参考仪器,以梅里埃VIDAS免疫荧光分析仪组成的检测系统作为研究对象,在两种不同检测系统上检测120例不同浓度水平的患者标本,对在不同检测系统测定的结果进行配对t检验及相关性分析.结果:120例不同浓度的β-HCG、孕酮在两个检测系统上的测定结果进行配对t检验的P值分别为0.554、0.569,均>0.05,结果差异无统计学意义;相关性分析显示相关系数分别为r2 0.9917、0.9946,均>0.95,符合美国临床化学实验室标准化委员会(NCCLS)的EP9-A2文件的要求.结论:两种不同的检测系统检测β-HCG、孕酮的结果具有较高的准确性和良好的相关性,可避免结果的差异给临床医生带来困扰,实验数据符合临床要求.

Objective: Based on the EP9—A2 document ofthe American Committee for Clinical Laboratory Standards (NCCLS), the results oftwo different detection systems in our hospital for the detection of p—HCG and progesterone were compared and analyzed for their comparability to achieve mutual recognition of different laboratory test results to provide experimental data basis. Methods: The detection system consisting of Beckman DXI —800 chemiluminometer was selected as the reference instrument. The detection system consisting of Merieux VIDAS immunofluorescence analyzer was used as the research object 120 different concentration levels were detected based on two different detection systems. Patient specimens were measured in different test systems was analyzed by paired t—test and correlation analysis. Results: The P values of 120 pairs of different concentrations of p-HCG and progesterone on the two detection systems were 0.554 and 0.569, respectively, and the results were all >0.05. The difierence was not statistically significant Correlation analysis showed The correlation coefficients were r2 0.9917 and 0.9946, both >0.95, which met the requirements of EP9 —A2 of the American Committee for Clinical Chemistry Laboratory Standardization (NCCLS). Conelusion: The results oftwo different detection systems for detecting p—HCG and progesterone have high accuracy and good correlation, which can avoid bringing the trouble of the difference of results to clinicians. The experimental data was in accordance with the clinical requirements.