三种CA125检测系统的一致性评价
| 作者: |
1张巧娣,
1谢而付,
1张燕,
1凌芸,
1蒋理,
1徐华国
1 南京医科大学第一附属医院检验学部，南京 210029 |
| 通讯: |
谢而付
Email: xieerfu791010@163.com |
| DOI: | 10.3978/j.issn.2095-6959.2015.01.017 |
| 基金: | 江苏省实验诊断学重点实验室基金, XK201114 国家自然科学基金, 81101322 江苏高校优势学科建设工程 资助项目 |
摘要
目的：使用Bland-Altman分析法，评估三种化学发光检测系统测定血清糖链抗原125 (cancer antigen， CA125)结果之间的一致性。方法：选取100例患者血清，分别使用Roche、Beckman和Siemens公司 的检测系统进行CA125检测，对每两种检测系统之间的检测结果进行相关性分析与Bland-Altman 分析，并绘制一致性限度作为评价一致性的指标。结果：Roche、Beckman和Siemens检测系 统检测CA125结果范围分别为5.6～279.8、4.5～542.4和4.5～350.0 U/mL；不同检测系统间相关系 数如下：Roche与Beckman为0.932 (P=0.000)，Roche与Siemens为0.947 (P=0.000)，Beckman与 Siemens为0.948 (P=0.000)，每两组之间均存在相关；Bland-Altman一致性分析结果如下：Roche 与Beckman、Roche与Siemens和Beckman与Siemens界限内的最大差值与均值的比值分别为46.6% (94.19/201.995)、52.85% (31.98/60.51)和42.02% (119.17/283.59)，均超出了CLIA’88规定的允许误 差范围的±25%，三种方法不具有一致性。结论：三种CA125检测系统之间数据不具有一致性，建 议对CA125建立标准化的参考系统，现有的检测系统应与标准化的参考系统进行比对。
关键词：
糖链抗原125
化学发光测定法
Bland-Altman分析
Measuring agreement in comparison of CA125 determined by three different immunoassay systems
CorrespondingAuthor: XIE Erfu Email: xieerfu791010@163.com
DOI: 10.3978/j.issn.2095-6959.2015.01.017
Abstract
Objective: To assess the agreement of three different chemiluminescent detection system of CA125 measurement by using Bland-Altman analysis. Methods: One hundreds serum samples were obtained from 100 patients. CA125 of these samples were measured by three different chemiluminescent detection system, including Roche, Beckman and Siemens. Bland-Altman analysis and Spearman correlation analysis were performed to assess the results of every two systems, and draw the limits of agreement as an evaluation of agreement of different systems. Results: The distribution of CA125 results of Roche, Beckman and Siemens system were 5.6~279.8, 4.5~542.4 and 4.5~350.0 U/mL, respectively. Spearman correlation analysis showed that the results of every two methods had good correlation, the correlation coefficient were 0.932 (P=0.000) between Roche and Beckman, 0.947 (P=0.000) between Roche and Siemens, 0.948 (P=0.000) between Beckman and Siemens. Bland-Altman analysis for the measurements showed bad relativity. The Bland-Altman plot revealed lower agreement between every two methods for CA125 results. Conclusion: Three detection systems do not have the consistency of the CA125 results, it is recommended to establish a standardized reference system of CA125 for comparison.