Concentration Estimation of Apixaban and Rivaroxaban in Plasma From Patients Through Heparin-Calibrated Anti-Xa Assay Generated Different Results by Using 3 Reagent/Calibrators/Instrument Systems

IF 2.3 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2025-05-14 DOI:10.1111/ijlh.14497

Marta Elba Martinuzzo, Claudio Sebastián Berger, Emanuel Sueldo, Claudio Martín Rosa, Marina Sol López, Verónica Privitera, Fernando Chuliber, Luis Horacio Barrera, Mirta Arias, José Ceresetto, Cristina Duboscq

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引用次数: 0

Abstract

Background

Direct oral anti-Xa inhibitors are widely used in thrombosis treatment or prophylaxis. Despite the high safety profile, in clinical practice, the measurement of drug concentration in plasma is sometimes needed.

Objective

The aim was to compare results of three branches of reagents/calibrators/coagulometers for Heparin Calibrated Anti Xa assays (HC-Anti Xa) in samples from patients taking apixaban (APIXA) or rivaroxaban (RIVA).

Methods

Population: 49 samples from patients receiving APIXA (32–703 ng/mL) and 40 receiving RIVA (< 8–573 ng/mL) taken at peak or trough. RIVA and APIXA measurement: HemosIL Liquid Anti Xa (Werfen) in ACL TOP 300 and STA-Liquid Anti Xa in STA Compact Max (Stago) with specific calibrators. HC-Anti Xa activity (1) HemosIL Heparin (Werfen) in ACL TOP 300; (2) Innovance Heparin (Siemens) in Sysmex CS-2500 (Siemens Health Care); (3) STA-Liquid Anti Xa (Stago) in STA COMPACT MAX coagulometer.

Results

HC-Anti Xa values paired compared showed statistically significant differences between the three systems, with the highest values obtained with the Stago system. An r ² > 0.94 was found for Werfen and Siemens with samples with any drug, but r ² of 0.800 for APIXA and 0.792 for RIVA was observed in the Stago System due to a tendency to plateau at high drug concentrations. Analyzing only samples with concentrations ≤ 200 ng/mL, an r ² > 0.93 with the three systems in APIXA (n = 30) samples and 0.913, 0.875, and 0.906 in RIVA (n = 31) samples with Werfen, Stago, and Siemens systems, respectively. Important differences inter systems in HC-Anti Xa calculated from regression lines were observed at 30, 50, 75, and 200 ng/mL of both drugs. Drug concentration measured by the Anti Xa assay calibrated with specific calibrators in 45 samples with APIXA and 27 with RIVA in Werfen and Stago systems showed very good correlation (r ² = 0.991 and 0.976, respectively).

Conclusion

Estimation of APIXA or RIVA concentration through HC-Anti Xa is possible, but values obtained are different for each reagent/calibrator/instrument system. Knowledge of the HC-Anti Xa values corresponding to anticoagulant concentrations at clinical decision points in the system used by each laboratory is mandatory to be able to use them correctly in the clinic.

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肝素校正抗xa法测定患者血浆中阿哌沙班和利伐沙班浓度在3种试剂/校准器/仪器系统中产生不同结果

背景：直接口服抗xa抑制剂广泛应用于血栓治疗或预防。尽管具有很高的安全性，但在临床实践中，有时需要测量血浆中的药物浓度。目的：比较使用阿哌沙班（APIXA）或利伐沙班（RIVA）患者样品中肝素校准抗Xa测定（HC-Anti Xa）的试剂/校准器/凝血仪三个分支的结果。方法：人群：49例接受APIXA （32-703 ng/mL）治疗的患者和40例接受RIVA治疗的患者(结果：HC-Anti - Xa值配对比较，三种系统之间差异有统计学意义，以Stago系统获得的值最高。在含有任何药物的样品中，Werfen和Siemens的r2为0.94，而在Stago系统中，APIXA的r2为0.800，RIVA的r2为0.792，这是由于在高药物浓度下趋于平稳。仅分析浓度≤200 ng/mL的样品，三种系统在APIXA （n = 30）样品中的r2 > 0.93，在RIVA （n = 31）样品中，使用Werfen、Stago和Siemens系统分别为0.913、0.875和0.906。在两种药物浓度分别为30、50、75和200 ng/mL时，通过回归线计算出的HC-Anti - Xa在系统间的重要差异。在Werfen体系和Stago体系中，45份APIXA样品和27份RIVA样品经特异性校准剂校准后的抗Xa含量测定结果具有很好的相关性（r2分别为0.991和0.976）。结论：用HC-Anti - Xa法测定APIXA或RIVA浓度是可行的，但不同试剂/校准器/仪器系统的测定值不同。了解每个实验室使用的系统中临床决策点抗凝血浓度对应的HC-Anti - Xa值是强制性的，以便能够在临床中正确使用它们。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.