BIOPHEN™ FIX (1)

Product Overview:

BIOPHEN™ FIX is a chromogenic method for the in vitro quantitative determination of Factor IX (FIX) activity on citrated human plasma or therapeutic concentrates. It is designed for automated or manual amidolytic methods. This assay is used to measure FIX activity, which is critical for diagnosing conditions like hemophilia B and monitoring patients with liver disorders, DIC, or those on anti-vitamin K therapy. High FIX levels may also indicate an increased risk of venous thrombosis. In vitro diagnostic kit for professional use only.

Key Features and Benefits:

• Specific Chromogenic Assay: Utilizes a highly specific chromogenic substrate (SXa-11) for Factor Xa, ensuring accurate measurement of FIX activity.
• Flexible Application: Suitable for both automated coagulation analysers and manual endpoint or kinetic methods.
• Versatile Sample Compatibility: Validated for the quantitative determination of Factor IX in both human citrated plasma and therapeutic concentrates.
• Comprehensive Reagent System: Includes activators (FXIa, Thrombin), cofactors (FVIII:C, PLPs), and substrate, with inhibitors included to prevent interference.

Principle and Application:

The BIOPHEN™ FIX method involves the chromogenic assay of Factor IX (FIX) activity. In the presence of phospholipids (PLPs) and calcium, Factor XIa (FXIa) activates the FIX present in the test specimen, converting it to activated Factor IX. Factor VIII:C, activated (FVIIIa) by thrombin, forms an enzyme complex with Factor IXa to activate Factor X. The resulting Factor Xa hydrolyzes the chromogenic substrate, leading to the release of paranitroaniline (pNa). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Factor IX in the specimen (Factor XIa, Factor VIII:C and Factor X are in constant excess amount).

Product Composition and Specifications:

This kit contains lyophilized reagents and a ready-to-use buffer for the REF 221801 configuration.

• R1 (Reagent 1): FX(h)-FVIII:C. Human Factor X and lyophilized FVIII:C. (2 vials of 1 mL)
• R2 (Reagent 2): Activator reagent. Lyophilized. Contains human Factor XIa, human thrombin, and synthetic phospholipids. (2 vials of 1 mL)
• R3 (Reagent 3): Substrate. Lyophilized chromogenic substrate specific to Factor Xa (SXa-11). (2 vials of 1 mL)
• R4 (Reagent 4): Buffer. Tris-BSA reaction buffer. Contains 1% BSA and 0.9 g/L sodium azide. (2 vials of 15 mL)
• Also Available: BIOPHEN™ FIX (221802) and BIOPHEN™ FIX (221806).

Reagents and Materials Required but Not Provided:

The following items are recommended for use but are not provided:

• Calibrators:
  • BIOPHEN™ Plasma Calibrator (222101)
• Controls:
  • BIOPHEN™ Normal Control Plasma (223201)
  • BIOPHEN™ Abnormal Control Plasma (223301)

Performance Characteristics:

Performance studies were conducted internally on a Sysmex CS-2000i analyser. Full details, including application guides for specific analysers, are available from the manufacturer.

• Measuring Range (Sysmex CS-2000i): 1% to 250% (high range) and 0.8% to 30% (low range).
• Detection Limit: Less than 2% (high range) and less than 0.5% (low range).
• Precision: A 20-day study (n=80) demonstrated strong precision. For high range, intra-series CVs were ≤ 2.4% and inter-series CVs were ≤ 5.6%. For low range, inter-series CVs were ≤ 6.4%.
• Correlation: Strong correlation (n=102, r=0.983) was shown against the STA® C.K. PREST® reference method (y = 0.97x – 0.10).
• Interferences (High Range): No significant interference observed for Intralipids (up to 1000 mg/dL), Hemoglobin (up to 1000 mg/dL), Dabigatran (up to 500 ng/mL), Bilirubin (F/C, up to 60 mg/dL), Apixaban (up to 50 ng/mL), or Heparin (UFH/LMWH, up to 2 IU/mL).

Storage and Stability:

• Unopened Vials: Store at 2-8°C. Stable until the expiration date printed on the label.
• Reconstituted R1, R2, R3 (for REF 221801): Stable for 24 hours at 2-8°C or 8 hours at room temperature (18-25°C) when stored closed and free from contamination.
• Reagent R4 (Ready-to-Use): Stable until the expiry date when stored at 2-8°C and kept free from contamination or evaporation.

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.