Wang Kun, Zang Xinwei, Zhang Wenjie, Cao Xiangyu, Zhao Huiru, Li Chunyan, Liang Cuiying, Wu Jun
Department of Clinical Laboratory, Beijing Jishuitan Hospital, Capital Medical University, Beijing, 100035, China.
Department of Clinical Laboratory, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, 550001, China.
Pract Lab Med. 2024 Jun 8;40:e00413. doi: 10.1016/j.plabm.2024.e00413. eCollection 2024 May.
D-dimer at a low level is important evidence for excluding the onset and progression of thrombosis. It is readily detectable and yields rapid results, although significant variability exists among different detection systems. Our study aims to enhance the consistency across various detection systems.
Twelve detection systems were included in our study. We sought to address this inconsistency by using various calibrators (two supplied by manufacturers and two comprising pooled human plasma diluted with different diluents) to standardize D-dimer measurements. We categorized the data into three groups according to D-dimer concentration levels: low (≤0.5 mg/L), medium (>0.5 mg/L - <3 mg/L), and high (≥3 mg/L). We then analyzed the data focusing on range, consistency, comparability, negative coincidence rate, and false negative rate.
Calibrating with pooled human plasma led to narrower result ranges in the low and medium groups (P < 0.05). In the low group, consistency improved from weak to strong (ICC 0.4-0.7, P﹤0.05), while it remained excellent in the other groups and overall (ICC﹥0.75, P﹤0.05). The percentage of pairwise comparability increased in both the low and high groups. Additionally, there was an increase in the negative coincidence rate.
These findings demonstrate that uniform calibration of D-dimer can significantly enhance the consistency of results across different detection systems.
低水平的D-二聚体是排除血栓形成和进展的重要证据。它易于检测且结果快速，尽管不同检测系统之间存在显著差异。我们的研究旨在提高各种检测系统之间的一致性。
我们的研究纳入了12种检测系统。我们试图通过使用各种校准物（两种由制造商提供，两种由用不同稀释剂稀释的混合人血浆组成）来标准化D-二聚体测量，以解决这种不一致性。我们根据D-二聚体浓度水平将数据分为三组：低（≤0.5mg/L）、中（>0.5mg/L - <3mg/L）和高（≥3mg/L）。然后我们分析数据，重点关注范围、一致性、可比性、阴性符合率和假阴性率。
用混合人血浆校准导致低、中组的结果范围变窄（P < 0.05）。在低组中，一致性从弱变强（ICC 0.4 - 0.7，P﹤0.05），而在其他组和总体中仍保持优异（ICC﹥0.75，P﹤0.05）。低、高组中两两可比性的百分比均增加。此外，阴性符合率有所提高。
这些发现表明，D-二聚体的统一校准可以显著提高不同检测系统之间结果的一致性。
