BIOPHEN™ Rivaroxaban Control Plasma

Product Overview:

BIOPHEN™ Rivaroxaban Control Plasma is designed for the quality control of Rivaroxaban assays using a quantitative automated method. These controls are specifically intended for verifying the performance of anti-Xa chromogenic assays, such as the BIOPHEN™ DiXaI and BIOPHEN™ Heparin LRT assays, within the standard measuring range. While routine monitoring of Rivaroxaban is not typically required, quantitative measurement may be useful in specific clinical situations, such as emergency surgery or suspected overdosage. In vitro diagnostic kit for professional use only.

Key Features and Benefits:

• Two-Level Control Set: Provides two distinct concentrations (approximately 100 ng/mL and 300 ng/mL) for comprehensive quality control across the standard therapeutic range.
• Human Plasma Matrix: Prepared from a human plasma base to closely mimic patient samples, ensuring commutable and reliable performance in the assay system.
• Traceable to Pharmacopoeia Standard: Directly traceable to the European Pharmacopoeia (Ph. Eur.) Certified Reference Standard for Rivaroxaban, ensuring high accuracy and confidence in results.
• Lyophilized for Stability: Supplied in a lyophilized format to ensure long-term stability and consistent performance upon reconstitution, minimizing lot-to-lot variability.

Principle and Application:

This product consists of lyophilized human plasmas containing known concentrations of Rivaroxaban. It is intended to be used as a quality control material to validate the performance and compliance of quantitative anti-Xa methods. The use of these controls helps to monitor the integrity of the reagents and the analytical system, as well as to ensure between-series assay homogeneity for a given batch of reagents. This product is suitable for the quality control of assays such as BIOPHEN™ DiXaI (221030) and the BIOPHEN™ Heparin LRT (221011) / (221013) / (221015) kits.

Product Composition and Specifications:

This product contains lyophilized human plasma with stabilizing agents.

• C1: Lyophilized human plasma containing approximately 100 ng/mL of Rivaroxaban.
• C2: Lyophilized human plasma containing approximately 300 ng/mL of Rivaroxaban.

Note: The control concentrations may vary slightly from one batch to another. For the assay, see the exact values indicated on the flyer provided with the kit used. The BIOPHEN™ Rivaroxaban Control Low (225101) is also available.

Traceability and Performance Characteristics:

Controls are traceable to the European Pharmacopoeia (Ph. Eur.) Certified Reference Standard for Rivaroxaban. Certificates of traceability and uncertainty are available on the manufacturer’s website.

• Lot-to-Lot Variability: The Coefficient of Variation (%CV) measured on 3 lots is ≤ 10%.
• Uncertainty:
  • C1: ± 15 ng/mL
  • C2: ± 15 ng/mL

Storage and Stability:

• Unopened Vials: Store at 2-8°C. Stable until the expiration date printed on the label.
• Reconstituted Vials: Stable for 7 days at 2-8°C or for 60 days when frozen at -20°C or less (thaw only once).

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.