Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls

Meyer Michel Samama; Genevieve Contant; Theodore E. Spiro; Elisabeth Perzborn; Céline Guinet; Yves Gourmelin; Léna Le Flem; Gabriele Rohde; Jean Luc Martinoli; for the Rivaroxaban Anti-Factor Xa Chromogenic Assay Field Trial Laboratories

doi:10.1160/TH11-06-0391

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2012; 107(02): 379-387
DOI: 10.1160/TH11-06-0391

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls

Meyer Michel Samama

¹Hótel-Dieu University Hospital, Paris, France

²Biomnis Laboratories R&D, Ivry-sur-Seine, France

,

Genevieve Contant

³Diagnostica Stago SA, Gennevilliers, France

,

Theodore E. Spiro

⁴Bayer Healthcare Pharmaceuticals Inc., Montville, New Jersey, USA

,

Elisabeth Perzborn

⁵Bayer HealthCare Pharmaceuticals AG, Wuppertal, Germany

,

Céline Guinet

²Biomnis Laboratories R&D, Ivry-sur-Seine, France

,

Yves Gourmelin

³Diagnostica Stago SA, Gennevilliers, France

,

Léna Le Flem

²Biomnis Laboratories R&D, Ivry-sur-Seine, France

,

Gabriele Rohde

⁵Bayer HealthCare Pharmaceuticals AG, Wuppertal, Germany

,

Jean Luc Martinoli

³Diagnostica Stago SA, Gennevilliers, France

,

for the Rivaroxaban Anti-Factor Xa Chromogenic Assay Field Trial Laboratories

› Author Affiliations

Abstract

Summary

Rivaroxaban is an oral, direct factor Xa inhibitor. Routine coagulation monitoring is not required, but a quantitative determination of rivaroxaban concentrations might be useful in some clinical circumstances. This multicentre study assessed the suitability of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations (ng/ml) using rivaroxaban calibrators and controls, and the inter-laboratory precision of the measurement. Twenty-four centres in Europe and North America were provided with sets of rivaroxaban calibrators (0, 41, 209 and 422 ng/ml) and a set of rivaroxaban pooled human plasma controls (20, 199 and 662 ng/ml; the concentrations were unknown to the participating laboratories). The evaluation was carried out over 10 days by each laboratory using local anti-factor Xa reagents as well as the centrally provided reagent, a modified STA^® Rotachrom^® assay. A calibration curve was produced each day, and the day-to-day precision was evaluated by testing three human plasma controls. When using the local anti-factor Xa reagents, the mean rivaroxaban concentrations (measured/actual values) were: 17/20, 205/199 and 668/662 ng/ml, and the coefficient of variance (CV) was 37.0%, 13.7% and 14.1%, respectively. When the modified STA Rotachrom method was used, the measured/actual values were: 18/20, 199/199 and 656/662 ng/ml, and the CV was 19.1%, 10.9% and 10.0%, respectively. The results suggest that, by using rivaroxaban calibrators and controls, the anti-factor Xa chromogenic method is suitable for measuring a wide range of rivaroxaban plasma concentrations (20–660 ng/ml), which covers the expected rivaroxaban plasma levels after therapeutic doses.

Keywords

Anti-factor Xa assay - calibrators and controls - plasma levels - rivaroxaban

Full Text

References

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