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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
1   Hótel-Dieu University Hospital, Paris, France
2   Biomnis Laboratories R&D, Ivry-sur-Seine, France
,
Genevieve Contant
3   Diagnostica Stago SA, Gennevilliers, France
,
Theodore E. Spiro
4   Bayer Healthcare Pharmaceuticals Inc., Montville, New Jersey, USA
,
Elisabeth Perzborn
5   Bayer HealthCare Pharmaceuticals AG, Wuppertal, Germany
,
Céline Guinet
2   Biomnis Laboratories R&D, Ivry-sur-Seine, France
,
Yves Gourmelin
3   Diagnostica Stago SA, Gennevilliers, France
,
Léna Le Flem
2   Biomnis Laboratories R&D, Ivry-sur-Seine, France
,
Gabriele Rohde
5   Bayer HealthCare Pharmaceuticals AG, Wuppertal, Germany
,
Jean Luc Martinoli
3   Diagnostica Stago SA, Gennevilliers, France
,
for the Rivaroxaban Anti-Factor Xa Chromogenic Assay Field Trial Laboratories › Institutsangaben Financial support: This study was supported by Bayer HealthCare Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Publikationsverlauf

Received: 09. Juni 2011

Accepted after major revision: 30. Oktober 2011

Publikationsdatum:
29. November 2017 (online)

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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
 

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