Eckschlager Christiane, Schwenoha Karin, Roth Caroline, Bogner Barbara, Oostingh Gertie Janneke
Biomedical Sciences, Salzburg University of Applied Sciences, Urstein Süd 1, 5412, Puch, Salzburg, Austria.
Pract Lab Med. 2019 Sep 19;17:e00137. doi: 10.1016/j.plabm.2019.e00137. eCollection 2019 Nov.
The use of point-of-care (POC) methods and the measurements of C-reactive protein (CRP) as a diagnostic marker have both increased over the past years. This has led to an increase in POC-methods analysing CRP. High CRP levels are often seen as an indication for the subscription of antibiotics. The quality of POC-systems compared to routine diagnostic measurements for the analysis of CRP is thereby of main importance, since many small practises will use POC-methods. This study compared high-level CRP concentrations (above 100 mg/L) using an i-CHROMA with 2 routinely used laboratory-based systems (Architect and ABX).
and Methods: A total of 199 patient samples with a CRP concentration above 100 mg/L were analysed with the i-CHROMA POC system and the turbidimetric routine methods using the Architect and ABX equipment.
The results of the i-CHROMA device showed a significant decrease in the CRP levels compared to those obtained with the Architect and the ABX (i-CHROMA vs. Architect: y = 0.6792x + 94.701; R = 0.4980, i-CHROMA vs. ABX: y = 0.3674x + 118.05; R = 0.3964, Architect vs. ABX: y = 0.7657x + 36.337; R = 0.9311). Furthermore, data analysis showed a partition of the i-CHROMA measurements in two defined clouds, which could not be explained with any of the available sample information.
This analysis showed the limitations of the i-CHROMA CRP analyser. In addition, it illustrates the need for strict regulations on the information and output provided by companies regarding the boundaries of novel and existing diagnostic methods.
在过去几年中,即时检验(POC)方法的使用以及将C反应蛋白(CRP)作为诊断标志物的检测均有所增加。这导致了分析CRP的POC方法的增多。高CRP水平常被视为开具抗生素的指征。因此,与用于分析CRP的常规诊断检测相比,POC系统的质量至关重要,因为许多小型诊所会使用POC方法。本研究使用i-CHROMA与2种常用的基于实验室的系统(Architect和ABX)比较了高水平CRP浓度(高于100mg/L)的情况。
使用i-CHROMA POC系统以及使用Architect和ABX设备的比浊法常规方法,对总共199份CRP浓度高于100mg/L的患者样本进行了分析。
与使用Architect和ABX获得的结果相比,i-CHROMA设备的结果显示CRP水平显著降低(i-CHROMA与Architect比较:y = 0.6792x + 94.701;R = 0.4980,i-CHROMA与ABX比较:y = 0.3674x + 118.05;R = 0.3964,Architect与ABX比较:y = 0.7657x + 36.337;R = 0.9311)。此外,数据分析显示i-CHROMA测量结果分为两个明确的簇,这无法用任何可用的样本信息来解释。
该分析显示了i-CHROMA CRP分析仪的局限性。此外,它说明了需要对公司提供的关于新型和现有诊断方法界限的信息和输出进行严格监管。