University Department of Laboratory Medicine, Desio Hospital, Via Mazzini 1, Desio, MB, Italy.
University Department of Laboratory Medicine, Desio Hospital, Via Mazzini 1, Desio, MB, Italy.
Clin Chim Acta. 2019 Apr;491:126-131. doi: 10.1016/j.cca.2019.01.025. Epub 2019 Jan 28.
The use of phase contrast in urinalysis has been highly recommended. A new system, sediMAX conTRUST PRO, is now available providing simultaneous automated phase contrast and bright field microscopy. This study aimed to evaluate both analytical and diagnostic performance of this new analyzer.
Results from 504 samples evaluated with the sediMAX conTRUST PRO were compared to those obtained from the same samples by manual microscopy (MM). Analytical and diagnostic performance were assessed according to established guidelines.
The concentration of red blood cells (RBCs)and white blood cells (WBCs) at which the LoQ satisfied a CV< 25% was 12 particles per μL (p/μL) and 8 p/μL, respectively. Within one grade of agreement concordance was quite high, 97.8% for RBCs and 98.0% for WBCs, and above 90% for all other particles. Overall, diagnostic sensitivity and specificity were good (>80%) for the particles considered, although lower sensitivities, 70.6% and 61.8%, were respectively found for hyaline and pathological casts.
The sediMAX conTRUST PRO provides very good performance in terms of RBC and WBC recognition and enumeration, and quite good performance for all other particles. Hyaline cast and pathological cast identification is fine and comparable to other automated systems, but could use further improvement.
尿液分析中应用相差技术已得到高度推荐。一种新系统，sediMAX conTRUST PRO，现已面世，可同时提供自动相差和明场显微镜检查。本研究旨在评估该新型分析仪的分析和诊断性能。
将 504 个样本的 sediMAX conTRUST PRO 检测结果与手动显微镜（MM）检查相同样本的结果进行比较。根据既定标准评估分析和诊断性能。
红细胞（RBC）和白细胞（WBC）的定量下限（LoQ）达到 CV<25%所需的浓度分别为 12 个颗粒/微升（p/μL）和 8 p/μL。在一级一致的情况下，一致性非常高，RBC 为 97.8%，WBC 为 98.0%，所有其他颗粒均超过 90%。总体而言，考虑到的颗粒具有良好的诊断灵敏度和特异性（>80%），尽管透明和病理性管型的灵敏度分别为 70.6%和 61.8%，相对较低。
sediMAX conTRUST PRO 在 RBC 和 WBC 识别和计数方面具有非常好的性能，在所有其他颗粒方面也具有相当好的性能。透明管型和病理性管型的识别良好且与其他自动化系统相当，但仍需进一步改进。
