BIOPHEN™ Rivaroxaban Plasma Calibrator

Product Overview:

BIOPHEN™ Rivaroxaban Plasma Calibrator is intended for the calibration of quantitative, automated chromogenic assays that measure Rivaroxaban concentrations in human plasma. This kit is used to establish the calibration curve for anti-Factor Xa (Anti-Xa) assays, including the BIOPHEN™ DiXaI (221030) and BIOPHEN™ Heparin LRT (221011/221013/221015) kits. In vitro diagnostic kit for professional use only.

Clinical Significance and Principle:

While routine therapeutic monitoring of Rivaroxaban is not required, its quantification in human plasma can be useful in specific clinical scenarios such as suspected overdosage, assessment of bleeding risk, or prior to emergency surgical procedures. This calibrator kit is used to establish a dose-response curve from which the concentration of Rivaroxaban in patient samples or controls can be determined. It consists of lyophilized human plasmas containing known, graded concentrations of Rivaroxaban.

Product Composition and Specifications:

The calibrator kit is provided as lyophilized human plasma containing stabilizers. The plasma has been screened and found negative for HBsAg, anti-HIV-1, anti-HIV-2, and anti-HCV antibodies. The kit includes three calibrator levels:

• CAL1: Lyophilized human plasma without Rivaroxaban.
• CAL2: Lyophilized human plasma containing approximately 250 ng/mL of Rivaroxaban.
• CAL3: Lyophilized human plasma containing approximately 500 ng/mL of Rivaroxaban.

Note: The exact concentration of each calibrator is lot-specific. Users must refer to the values provided on the flyer included with the assay kit in use. The BIOPHEN™ Rivaroxaban Calibrator Low (226001) kit is also available.

Traceability and Performance Characteristics:

The calibrators are traceable to the European Pharmacopoeia (Ph. Eur.) Certified Reference Standard for Rivaroxaban. A certificate of traceability and uncertainty is available upon request.

• Lot-to-Lot Variability: The coefficient of variation (%CV) between manufacturing lots is maintained at ≤ 10%.
• Measurement Uncertainty: The uncertainty for each calibrator level is:
  • CAL1: ± 0.0 ng/mL
  • CAL2: ± 15 ng/mL
  • CAL3: ± 36 ng/mL

Storage and Stability:

• Unopened Vials: Store at 2-8°C. The product is stable until the expiration date printed on the label.
• Reconstituted Calibrators: When stored in a closed vial to prevent contamination and evaporation, the calibrators are stable for:
  • 7 days at 2-8°C.
  • 60 days when frozen at -20°C or below.
  • Important: Reconstituted material should be thawed only once. Thaw rapidly at 37°C and use immediately.
  • For on-board stability on automated analyzers, please refer to the specific Application Guide.

Quality Control:

In accordance with Good Laboratory Practice (GLP), a new calibration curve should be established for each test series, for each new reagent batch, after analyzer maintenance, or when measured quality control values fall outside the established acceptance range for the method. The use of quality controls serves to validate method compliance and ensure between-series assay homogeneity.

Disclaimer:

The information on this page is for informational purposes and serves as a general summary. It is imperative that all users read and strictly follow the Instructions for Use (IFU) document provided with the reagent or kit they are using. This online description must not be a substitute for the official product documentation.