一种基于时间分辨免疫荧光法的免疫分析仪检测降钙素原的性能评估

Evaluation of a time resolved immunofluorescence immunoassay system in procalcitonin detection

目的评估一种基于时间分辨免疫荧光法的免疫分析仪检测降钙素原(PCT)的性能。方法采用第三方质控品朗道PCT质控品两个水平(高值和低值)对其进行精密度检测。分别采用朗道高值质控品和患者混合高值血浆对其进行线性检测。选取103例患者的血液标本,与参考方法生物梅里埃VIDAS 30进行方法学比对。结果精密度方面,朗道两个水平的质控待评估方法变异系数均<10%。线性方面,采用朗道高值质控和患者混合高值血浆来检测线性范围,待考核方法检测值与理论值的r2均达到>0.99的要求。采用临床标本进行相关性分析时,测量结果的差值对均值的Bland-Altman分析及测量结果比值对均值的Bland-Altman分析显示二者的相关性较好。待考核方法与VIDAS 30的Spearman相关系数为0.98,P<0.000 1。结论待考核方法定量检测全血PCT,操作简便,具有较好的精密度,在检测临床标本时与生物梅里埃VIDAS 30检测PCT有较好的一致性,适用于急诊检查和床旁检测。

Objective To evaluate the performance of a time resolved immunofluorescence immunoassay system in procalcitonin detection. Methods Two levels (high and low) Randox procalcitonin quality control products were used to detect precision.Using Randox high level quality control product and mixed high concentration patient plasma for linear detection.A total of 103 patients′ specimens were used for comparison with reference method VIDAS 30. Results In precision tests,the CV of both two levels Randox quality control were less than 10%.For linearity tested with Randox high-level quality control and mixed patients plasma,both of their r 2 (the correlation coefficient between the detection value and the theoretical value) were greater than 0.99.The Bland-Altman analysis of the difference-to-mean and the ratio-to-mean of the measurement results of clinical specimens showed that the correlation between the two methods was good.The Spearman correlation coefficient between Radiometer and VIDAS 30 was 0.98 and P <0.000 1. Conclusion The system for detection of whole blood PCT to be evaluated is easy to operate and with good precision and good correlation with VIDAS 30.It is suitable for using in emergency and point of care testing.