PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: These findings demonstrate that uniform calibration of D-dimer can significantly enhance the consistency of results across different detection systems.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: These findings demonstrate that uniform calibration of D-dimer can significantly enhance the consistency of results across different detection systems.
摘要：
■低水平的D-二聚体是排除血栓形成的发生和进展的重要证据。它易于检测并产生快速结果，尽管不同的检测系统之间存在显著的差异。我们的研究旨在提高各种检测系统的一致性。
■我们的研究中包括了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,两种包含用不同稀释剂稀释的汇集的人血浆)来标准化D-二聚体测量来解决这种不一致。我们根据D-二聚体浓度水平将数据分为三组：低（≤0.5mg/L），培养基（>0.5mg/L-<3mg/L），和高（≥3mg/L）。然后我们分析了关注范围的数据，一致性,可比性，负符合率,和假阴性率。
■用合并的人血浆校准导致低和中等组的较窄的结果范围(P<0.05)。在低群体中，一致性由弱变强(ICC0.4-0.7,P﹤0.05),而其他组和总体仍优异(ICC>0.75，P﹤0.05)。低组和高组的成对可比性百分比均增加。此外,负符合率增加。
■这些发现表明，D-二聚体的均匀校准可以显着增强跨不同检测系统的结果一致性。
■我们的研究中包括了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,两种包含用不同稀释剂稀释的汇集的人血浆)来标准化D-二聚体测量来解决这种不一致。我们根据D-二聚体浓度水平将数据分为三组：低（≤0.5mg/L），培养基（>0.5mg/L-<3mg/L），和高（≥3mg/L）。然后我们分析了关注范围的数据，一致性,可比性，负符合率,和假阴性率。
■用合并的人血浆校准导致低和中等组的较窄的结果范围(P<0.05)。在低群体中，一致性由弱变强(ICC0.4-0.7,P﹤0.05),而其他组和总体仍优异(ICC>0.75，P﹤0.05)。低组和高组的成对可比性百分比均增加。此外,负符合率增加。
■这些发现表明，D-二聚体的均匀校准可以显着增强跨不同检测系统的结果一致性。
