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评估乙二胺四乙酸(EDTA)血浆中D-二聚体检测的可靠性:与既定的柠檬酸盐法比较。

Assessing the Reliability of D-Dimer Measurement in EDTA Plasma: A Comparison to the Established Citrate Method.

作者信息

Pfingst Daniel, Méndez Adriana, Neyer Peter, Nilius Henning, Schaub Nicole, Keusch Patricia, Nagler Michael, Hammerer-Lercher Angelika

机构信息

Institute of Laboratory Medicine, Cantonal Hospital Aarau, 5001 Aarau, Switzerland.

Department of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.

出版信息

Diagnostics (Basel). 2025 Jul 6;15(13):1720. doi: 10.3390/diagnostics15131720.

Abstract

D-dimer determined in citrated plasma is a well-established and efficient biomarker, particularly for ruling out venous thromboembolism. In certain clinical settings, the availability of citrated plasma may pose challenges when not readily available. To address this issue, we investigated the feasibility of using ethylenediaminetetraacetic acid (EDTA) plasma as an alternative specimen for D-dimer measurement. Our study evaluated anonymized plasma samples (n = 99, for both citrate and EDTA) using the INNOVANCE D-dimer assay, an automated particle-enhanced immunoassay, and the INNOVANCE LOCI hs D-dimer assay, leveraging the luminescent oxygen channeling assay (LOCI) method. The assays demonstrated a correlation of r ≥ 0.97 (95% CI 0.96 to 0.98) within citrated plasma and maintained a similar correlation r ≥ 0.96 (95% CI 0.94 to 0.97) between citrate and EDTA plasma upon correction for the dilution effect of the sodium citrate solution. : These results indicate that the utilization of EDTA instead of citrate plasma is feasible and may provide similar diagnostic information. However, the observed variance could have an impact on clinical interpretation and risk assessment. Therefore, future studies are needed to confirm the results and, if necessary, determine cut-off values and clinical performance.

摘要

在枸橼酸盐血浆中测定的D-二聚体是一种成熟且有效的生物标志物,尤其用于排除静脉血栓栓塞症。在某些临床环境中,若枸橼酸盐血浆难以即时获取,其可用性可能带来挑战。为解决这一问题,我们研究了使用乙二胺四乙酸(EDTA)血浆作为D-二聚体检测替代样本的可行性。我们的研究使用INNOVANCE D-二聚体检测法(一种自动化颗粒增强免疫测定法)和INNOVANCE LOCI hs D-二聚体检测法(利用发光氧通道测定法(LOCI))对匿名血浆样本(枸橼酸盐和EDTA样本各99份)进行了评估。这些检测法在枸橼酸盐血浆中显示出r≥0.97(95%置信区间0.96至0.98)的相关性,在校正枸橼酸钠溶液的稀释效应后,枸橼酸盐血浆和EDTA血浆之间保持了相似的相关性r≥0.96(95%置信区间0.94至0.97)。这些结果表明,使用EDTA而非枸橼酸盐血浆是可行的,并且可能提供相似的诊断信息。然而,观察到的差异可能会对临床解释和风险评估产生影响。因此,需要未来的研究来证实这些结果,并在必要时确定临界值和临床性能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/857e/12248503/7b932f2c6b25/diagnostics-15-01720-g001.jpg

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