Objective

To evaluate the analytical performance of our previously developed chemiluminescence immunoassay (CLIA) kit for the detection of procalcitonin (PCT) and compare with the results obtained using the Vidas B.R.A.H.M.S. PCT™ test (PCT-V).

Design and methods

Our laboratory previously designed a novel CLIA kit and supporting instrument (AE-180) for the detection of PCT. We analyzed the clinical performance of this system, including the imprecision, limit of detection, and linearity of analyses of 305 serum specimens. The results were compared with measurements of the same serum samples obtained with PCT-V.

Results

The limit of detection and blank of our kit were 0.0075 and 0.0039 ng/mL, respectively. The intra- and inter-assay coefficient of variation of the kit were both between 0.8% and 3.9%. The equation of linearity was found to be y = 1.03× + 0.06 (r = 0.99) for concentrations in the range of 0.01–110 ng/mL. The correlation coefficient with the results of PCT-V was 0.995, and the equation obtained for Passing and Bablok regression analysis was 1.061 for our CLIA PCT kit and − 0.003 for PCT-V. Our kit slightly overestimated the concentration according to comparison with PCT-V results.

Conclusion

The kit that was previously developed in our laboratory for the measurement of serum PCT concentration using CLIA technology shows excellent performance, just that the functional sensitivity is not as good as the PCT-V; therefore, we suggest that this kit is suitable for clinical use.

中文翻译：

---

用于检测降钙素的新型化学发光免疫分析方法的开发。

目的

为了评估我们先前开发的化学发光免疫分析（CLIA）试剂盒检测降钙素（PCT）的分析性能，并与使用Vidas BRAHMS PCT™测试（PCT-V）获得的结果进行比较。

设计与方法

我们的实验室以前设计了一种新颖的CLIA套件和支持仪器（AE-180），用于检测PCT。我们分析了该系统的临床性能，包括不精确性，检测限和305个血清标本分析的线性。将结果与用PCT-V获得的相同血清样品的测量结果进行比较。

结果

我们试剂盒的检出限和空白分别为0.0075和0.0039 ng / mL。试剂盒的测定内和测定间变异系数都在0.8％和3.9％之间。发现 浓度在0.01-110 ng / mL范围内时，线性方程为y = 1.03×+ 0.06（r = 0.99）。与PCT-V结果的相关系数为0.995，对于我们的CLIA PCT试剂盒，Passing和Bablok回归分析获得的方程为1.061，而PCT-V为− 0.003。根据与PCT-V结果的比较，我们的试剂盒略微高估了浓度。

结论

先前在我们实验室中使用CLIA技术测量血清PCT浓度的试剂盒显示了出色的性能，只是其功能敏感性不如PCT-V。因此，我们建议该试剂盒适合临床使用。