两种血清降钙素原检测系统的方法学对比及偏差评估

Methodological assessment and bias estimation of two serum procalcitonin analysis systems

目的通过对同一实验室不同检测系统血清降钙素原(PCT)测定进行方法学对比和预期偏差评估,探讨不同检测系统间PCT检测结果是否具有可比性和检测结果的偏差是否在允许范围内。方法参照EP9-A文件要求,以Roche e601全自动电化学发光免疫分析检测系统为参考方法,广州万孚WF-0901/1型免疫荧光检测系统为对比方法,对患者血清PCT进行检测,计算相关系数和直线回归方程,对两个检测系统之间的预期偏差进行评估。结果 PCT测定结果在两个检测系统间经配对t检验分析P>0.05,差异无统计学意义,相关系数大于0.975,一致性检验kappa值均大于0.75,一致性良好。结论广州万孚WF-0901/1型免疫荧光检测系统与Roche e601全自动电化学发光免疫分析检测系统PCT检测结果具有可比性,能够满足临床检测要求。

Objective To evaluate the comparability and bias of the test results of two detection systems for serum procalcitonin （PCT） under the same laboratory condition. Methods According to the profile NCCLS-EP9-A, the two systems were used to detect PCT to obtain the correlation coefficient and the liner equation for evaluation of the test result bias. Results and Conclusion The test results of PCT showed no significant difference between the two detection systems （P＆gt;005） with a kappa value greater than 0.75.The correlation coefficients of both systems were above 0.975, suggesting a consistency between them for clinical detection of PCT.