vW FACTOR ASSAY®
Ristocetin CoFactor Assay Test Kit

vW Factor Assay® Kit: Trusted Gold Standard for Precise Von Willebrand Syndrome Assessment

vW Factor Assay® (Ristocetin CoFactor) Test Kit is a system of reagents and control plasmas that causes lyophilized platelets to agglutinate in the presence of patient Platelet Poor Plasma and Ristocetin for evaluation of von Willebrand Syndrome.

Tests Patient Samples for Ristocetin CoFactor Activity
Offers a Three or Four Point Standard Curve
Achieves Linear Standard Curves
Replaces Lab Developed Tests for Regulatory Compliance
Shows Inflammatory Responses
Includes Lot Specific Assay Value Sheet
Use with Most Light Transmission Aggregometers
Plasmas Traceable to WHO Standard Reference Plasma
Suitable for Veterinary Use

The vW Factor Assay® (Ristocetin Cofactor) Test Kit stands as a comprehensive system designed for the evaluation of von Willebrand Syndrome through meticulous testing of patient samples. This innovative kit is built upon a foundation of reagents and control plasmas that induce lyophilized platelets to agglutinate in the presence of patient Platelet Poor Plasma and Ristocetin. It is a sophisticated solution that not only tests for Ristocetin Cofactor activity but also offers a range of features for enhanced precision and regulatory compliance.

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One of the key functionalities of the test kit is its ability to test patient samples for Ristocetin Cofactor activity, providing critical insights into the von Willebrand factor's in vitro activity. This factor is responsible for the agglutination of platelets in the presence of Ristocetin. Quantifying Ristocetin Cofactor activity is particularly valuable in diagnosing and evaluating von Willebrand syndrome, where decreased von Willebrand factor levels are associated with this coagulopathy.

The vW Factor Assay® Test Kit goes beyond basic testing by offering a Three or Four Point Standard Curve, ensuring a more nuanced and accurate assessment. It achieves linear standard curves, adding a layer of precision to the diagnostic process. Notably, it replaces traditional Lab Developed Tests, aligning with regulatory compliance standards and streamlining diagnostic procedures.

Furthermore, the Ristocetin Cofactor Assay test kit is designed to reveal inflammatory responses, providing a more comprehensive understanding of the patient's condition. Each kit includes a Lot Specific Assay Value Sheet, contributing to documentation and traceability. Compatible with most Light Transmission Aggregometers, this kit offers versatility in laboratory settings.

For ease of use, the plasmas included in the kit are traceable to the WHO Standard Reference Plasma, ensuring consistency and reliability in results. Additionally, the kit is suitable for veterinary use, expanding its applicability across different medical domains.

The 20-determination complete test kit comes equipped with essential components, including Lyophilized Platelets, Ristocetin Reagent, vW Normal Reference Plasma, vW Abnormal Control Plasma, Tris Buffered Saline, and Graph Paper. This comprehensive package provides healthcare professionals with a reliable and efficient tool for the thorough evaluation of von Willebrand Syndrome, contributing to advancements in hematology diagnostics.

Carefully examine the provided documentation, covering the vW Factor Assay® Product Data Sheet and Ristocetin Cofactor Assay Simplified Instructions. Additionally, scrutinize the vW Factor Assay® Instruction for Use (IFU) and the vW Factor Assay® Safety Data Sheet (SDS), both available in six languages. Thoroughly investigate the vW Factor Assay® EU and UK Declaration of Conformity for our European and UK clients and distributors, ensuring adherence and a tailored understanding for these specific markets. It is vital to review this information meticulously to obtain a comprehensive understanding of the product's details and specifications.

Bio/Data Corporation’s Aggregation Reagents: Accessible Safety Data Sheets for Secure Handling

Bio/Data Corporation provides comprehensive Safety Data Sheets (SDS) for each of its carefully formulated aggregation reagents. These essential documents ensure safe handling, storage, and spill management while offering clear instructions on potential hazards. Designed for easy viewing, saving, and printing, the SDS are readily accessible to support a safe work environment and responsible chemical management.

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Product Description

The vW Factor Assay® Kit is a system of reagents and control plasmas for the evaluation of von Willebrand Syndrome.

Intended Purpose

vW Factor Assay® (Ristocetin Cofactor) Kit is a system of reagents and control plasmas that causes lyophilized platelets to agglutinate in the presence of patient Platelet Poor Plasma and Ristocetin for evaluation of von Willebrand Syndrome.

Test Principle

Ristocetin cofactor is the in vitro activity of the von Willebrand factor which is responsible for the agglutination of platelets in the presence of Ristocetin. Decreased von Willebrand factor is associated with von Willebrand syndrome, thus making quantitation of Ristocetin Cofactor activity most valuable in the diagnosis and evaluation of this coagulopathy. Levels of Ristocetin Cofactor activity are determined by the ability of a test plasma and ristocetin to induce agglutination of a standardized platelet suspension.

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Reagents Provided

Lyophilized Platelets, 2 x 4.0mL.

Ristocetin Reagent, 2 x 0.5mL.

vW Normal Reference Plasma, 2 x 0.5mL.

vW Abnormal Control Plasma, 2 x 0.5mL.

Tris Buffered Saline, 2 x 10mL.

Graph Paper, 2 Each.

Reagents and Materials Required but Not Provided

Purified Water (Distilled, Deionized, Reagent Grade), pH 5.3 – 7.2 for reconstitution

Materials and Accessories

Platelet Aggregometer
Centrifuge
Electronic Pipette
Pipette Tips
Aggregometer Test Tubes (Siliconized)
Aggregometer Stir Bars (Plastic Coated)
Plastic Sample Tubes and Caps (For Dilutions)

Reagent Storage

Upon receipt, store Lyophilized Platelets, Ristocetin Reagent, vW Abnormal Control Plasma, Reference Plasma, and TRIS Buffered Saline at 2 – 8° C in its original packaging.
Reconstituted Lyophilized Platelets is stable for 30 days when stored in its’ tightly capped, original container at 2 – 8° C.
Reconstituted Ristocetin Reagent is stable for 7 days when stored in its’ tightly capped, original container at 2 – 8° C.
Reconstituted vW Abnormal Reference Plasma is stable for 8 hours when stored in its’ tightly capped, original container at 2 – 8° C.
Reconstituted vW Normal Reference Plasma is stable for 8 hours when stored in its’ tightly capped, original container at 2 – 8° C.
Dilutions using vW Abnormal Control Plasma or vW Normal Reference Plasma are less stable and must be used within 40 minutes of preparation.

Bio/Data Corporation's Commitment to IVDR Compliance
Bio/Data Corporation proudly complies with the stringent EU In Vitro Diagnostic Regulation (IVDR) 2017/746 and other relevant legislation. Through its Declaration of Conformity (DOC), the company ensures that its devices meet essential health, safety, and environmental standards.

Bio/Data Corporation's Commitment to UKCA Compliance
Bio/Data Corporation ensures product excellence by strictly adhering to UKCA regulations. The company's Declaration of Conformity (DOC) affirms its dedication to meeting health, safety, and environmental standards outlined in UKCA directives and any related updates, demonstrating its unwavering commitment to compliance.

View EU Declaration of Conformity