BIOPHEN™ Rivaroxaban Calibrator Low

Product Overview:

BIOPHEN™ Rivaroxaban Calibrator Low is used to establish the calibration curve for the quantitative determination of Rivaroxaban in human plasma using automated, anti-Xa chromogenic assays. This calibrator set is suitable for use with assays such as the BIOPHEN™ DiXaI (221030) and BIOPHEN™ Heparin LRT (221011/221013/221015) kits. In vitro diagnostic kit for professional use only.

Clinical Significance and Principle:

Rivaroxaban is an oral, direct inhibitor of Factor Xa. While routine therapeutic monitoring is not typically required, the quantification of its plasma concentration can be informative in certain clinical situations, such as suspected overdosage, assessment of bleeding risk, or prior to emergency surgical procedures. This calibrator set is used to generate a dose-response curve from which the concentration of Rivaroxaban in patient samples can be interpolated.

Product Composition and Specifications:

The calibrator set consists of lyophilized human plasma containing stabilizers. The plasma has been screened and found negative for HBsAg and for antibodies to HIV-1, HIV-2, and HCV. The kit includes three calibrators for the low range:

• CALI: Lyophilized human plasma without Rivaroxaban (0 ng/mL).
• CALII: Lyophilized human plasma containing approximately 50 ng/mL of Rivaroxaban.
• CALIII: Lyophilized human plasma containing approximately 100 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 Plasma Calibrator (222701) 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 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:
  • CALI: ± 0.0 ng/mL
  • CALII: ± 2.4 ng/mL
  • CALIII: ± 4.2 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), quality control samples should be included in each series of tests to validate method compliance. 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.

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.