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

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH11-06-0391
Issue: 2012: 107/2 (Feb) pp. 201-395
Pages: 379-387

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

M. M. Samama (1, 2), G. Contant (3), T. E. Spiro (4), E. Perzborn (5), C. Guinet (2), Y. Gourmelin (3), L. Le Flem (2), G. Rohde (5), J. L. Martinoli (3), for the Rivaroxaban Anti-Factor Xa Chromogenic Assay Field Trial Laboratories

(1) Hôtel-Dieu University Hospital, Paris, France; (2) Biomnis Laboratories R&D, Ivry-sur-Seine, France; (3) Diagnostica Stago SA, Gennevilliers, France; (4) Bayer HealthCare Pharmaceuticals Inc., Montville, New Jersey, USA; (5) Bayer HealthCare Pharmaceuticals AG, Wuppertal, Germany

Keywords

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

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 anti­factor 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.

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