ZYMUTEST™ vWF

Product Overview:

ZYMUTEST™ vWF is a sandwich ELISA method for the in vitro quantitative determination of von Willebrand Factor (vWF) on human plasma. vWF is a critical multimeric protein that mediates platelet adhesion to the subendothelium and complexes with Factor VIII to extend its half-life. This assay is used to assess vWF concentration, which is essential for diagnosing von Willebrand disease (vWD) and can also be indicative of inflammatory processes. In vitro diagnostic kit for professional use only.

Key Features and Benefits:

• Quantitative ELISA Method: Provides a quantitative measurement of von Willebrand Factor (vWF) antigen concentration.
• Standardized and Traceable: The vWF calibrator is referenced against the NIBSC international standard.
• High Specificity: Utilizes rabbit polyclonal antibodies highly specific for human vWF, ensuring accurate detection.
• Comprehensive Kit: Includes coated microplate, calibrator, high and low controls, conjugate, and all necessary diluents and buffers for 96 tests.

Principle and Application:

This assay is a sandwich ELISA method based on an antigen-antibody reaction. The vWF antigen from the sample is captured by anti-vWF polyclonal antibodies coated onto the microwell. Following a washing step, the captured vWF is detected by an anti-(h)-vWF polyclonal antibody coupled to Horseradish Peroxidase (HRP). After a second wash, the peroxidase substrate (TMB) is added, developing a blue color. The reaction is stopped with Sulfuric Acid, turning the color yellow. The absorbance, measured at 450 nm, is directly proportional to the concentration of human vWF in the sample.

Product Composition and Specifications:

This kit contains reagents for 96 tests. Reagents include:

• COAT: 1 microplate (12 strips of 8 wells) coated with rabbit polyclonal antibody specific for human vWF. Contains sodium azide (0.9 g/L).
• SD ELISA: 2 x 50 mL Sample Diluent (ready to use). Contains Proclin and BSA.
• CAL vWF: 3 vials of vWF calibrator (lyophilized). Referenced to the NIBSC international standard. Contains BSA.
• CI vWF: 1 vial of vWF Control high (lyophilized).
• CII vWF: 1 vial of vWF Control low (lyophilized).
• IC ANTI-(h)-vWF HRP: 3 vials of Anti-(h)-vWF-HRP immunoconjugate (lyophilized). Rabbit polyclonal antibody coupled to HRP. Contains BSA.
• CD ELISA: 1 x 25 mL Conjugate diluent (ready to use). Contains Proclin and BSA.
• WS ELISA: 1 x 50 mL Wash solution (20x concentrated). Contains Proclin.
• TMB: 1 x 25 mL 3,3′,5,5′-Tetramethylbenzidine substrate (ready to use). Contains hydrogen peroxide.
• Stop: 1 x 6 mL 0.45M Sulfuric acid (ready to use).

Note: Calibrator and control concentrations are lot-specific and provided on the flyer included in the kit.

Traceability and Performance Characteristics:

The vWF calibrator is referenced to the NIBSC international standard. Performance characteristics are as follows:

• Dynamic range: 0 to 150%.
• Detection threshold: ≤ 5%.
• Intra-assay variability: 3-8 %.
• Inter-assay variability: 5-10 %.
• Interferences: No interference observed with Heparin (up to 2 IU/mL), Bilirubin (up to 0.05 mg/mL), or Hemoglobin (up to 10 mg/mL).

Storage and Stability:

• Unopened Reagents: Store at 2-8°C. Stable until the expiration date printed on the label.
• Reconstituted Calibrator (CAL vWF): Stable for 8 hours at room temperature (18-25°C).
• Reconstituted Controls (CI vWF, CII vWF): Stable for 24 hours at 2-8°C, 8 hours at room temperature, or 2 months frozen at -20°C or less (thaw only once).
• Reconstituted Conjugate (IC ANTI-(h)-vWF HRP): Stable for 4 weeks at 2-8°C or 24 hours at room temperature.
• Opened Reagents (SD ELISA, CD ELISA, TMB, Stop): Stable for 4-8 weeks at 2-8°C (see IFU for specific reagent details).
• Diluted Wash Solution (WS ELISA): Stable for 7 days at 2-8°C.
• Unused Strips (COAT): Stable for 4 weeks at 2-8°C when stored in the original hermetically sealed pouch with desiccant.

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.