BIOPHEN™ Heparin (LRT)

Product Overview:

BIOPHEN™ Heparin LRT is an anti-Xa chromogenic method for the in vitro quantitative determination of Factor Xa (FXa) inhibitors in human citrated plasma. It is intended for monitoring patients on Heparin (UFH/LMWH), Arixtra®, or Orgaran® therapy, and for specific clinical situations involving oral anticoagulants such as Apixaban, Rivaroxaban, and Edoxaban. In vitro diagnostic kit for professional use only.

Principle and Application:

This method is a one-stage chromogenic assay based on the inhibition of a constant, excess amount of Factor Xa (FXa) by the anti-Xa substance present in the sample, in the presence of endogenous antithrombin (AT). The residual FXa then hydrolyses a specific chromogenic substrate, releasing para-Nitroaniline (pNA). The amount of pNA released, measured by absorbance at 405 nm, is inversely proportional to the concentration of the anti-Xa inhibitor in the sample.

Product Composition and Specifications:

This kit contains liquid, ready-to-use reagents.

• R1: Chromogenic substrate specific for Factor Xa (CS-11(32)) at approximately 2 mg/mL.
• R2: Bovine Factor Xa at approximately 4.5 U/mL. Contains BSA and Dextran Sulfate.

Note: The BIOPHEN™ Heparin LRT (221013) and BIOPHEN™ Heparin LRT (221015) are also available.

Reagents and Materials Required but Not Provided:

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

• Buffers & Diluents:
  • Isotonic Sample Diluent (AR034K) / Isotonic Sample Diluent (AR034L)
  • Tris-NaCl-EDTA buffer, pH 7.85 (AR032A) / Tris-NaCl-EDTA buffer, pH 7.85 (AR032K)
• Calibrators:
  • BIOPHEN™ Apixaban Calibrator (226201) / Low (226101)
  • BIOPHEN™ Arixtra® Calibrator (222501)
  • BIOPHEN™ Edoxaban Calibrator (226501) / Low (226401)
  • BIOPHEN™ Heparin Calibrator (222001)
  • BIOPHEN™ Orgaran® Calibrator (222201)
  • BIOPHEN™ Rivaroxaban Plasma Calibrator (222701) / Low (226001)
  • BIOPHEN™ UFH Calibrator (222301)
• Controls:
  • BIOPHEN™ Apixaban Control (225301) / Low (225201)
  • BIOPHEN™ Arixtra® Control Plasma (224001)
  • BIOPHEN™ Edoxaban Control (225501) / Low (225401)
  • BIOPHEN™ LMWH Control Plasma (223001) / C3 (223801) / C4 (224201) / Low (223701) / Low CI (224301) / Low CII (224401)
  • BIOPHEN™ Orgaran® Control (223501)
  • BIOPHEN™ Rivaroxaban Control Plasma (224501) / Low (225101)
  • BIOPHEN™ UFH Control Plasma (223101) / C1 (224101) / C2 (223901)

Traceability and Performance Characteristics:

Certificates of traceability for calibrators and controls are available on the manufacturer’s website. Performance studies were conducted as described in CLSI guidelines on various automated platforms.

• Measuring Range: Dependent on the analyser system used (see specific Application Guides).
• Precision: Repeatability, reproducibility, and within-laboratory Coefficient of Variation (CV) are all less than 10%.
• Interfering Substances: This assay is designed to limit interference from Platelet Factor 4 (PF4) up to 0.1 µg/mL. Antithrombin (AT) concentrations ≤50% or >170% may interfere with the assay. With the use of Tris-NaCl-EDTA buffer (pH 7.85), no interference from Heparin (UFH, LMWH) is expected in Direct FXa-inhibitor assays up to 2 IU/mL.

Agreement:

• On ACL-TOP® family:
  • UFH (n=145): y = 1.06x + 0.08, r = 0.978
  • LMWH (n=142): y = 1.28x + 0.03, r = 0.992
  • Orgaran® (n=163): y = 1.08x – 0.01, r = 0.995
  • Arixtra® (n=153): y = 1.00x + 0.05, r = 0.992
  • Apixaban (n=150): y = 0.90x + 10.72, r = 0.994
  • Rivaroxaban (n=153): y = 1.20x + 0.66, r = 0.995
• On STA-R® family:
  • Edoxaban (n=152): y = 0.82x + 4.11, r = 0.966
• On CS-series:
  • UFH/LMWH (n=182): y = 1.09x + 0.06, r = 0.959

Sensitivity/Specificity:

• On ACL-TOP® family:
  • UFH (n=145): Sensitivity 0.939, Specificity 1.000, AUC 0.999
  • LMWH (n=142): Sensitivity 0.970, Specificity 0.991, AUC 0.998
  • Orgaran® (n=163): Sensitivity 0.970, Specificity 0.969, AUC 0.991
  • Arixtra® (n=153): Sensitivity 0.970, Specificity 1.000, AUC 1.000
  • Apixaban (n=150): Sensitivity 1.000, Specificity 0.966, AUC 0.995
  • Rivaroxaban (n=153): Sensitivity 1.000, Specificity 0.996, AUC 0.996
• On STA-R® family:
  • Edoxaban (n=152): Sensitivity 1.000, Specificity 0.958, AUC 1.000

Storage and Stability:

• Unopened Vials: Store at 2-8°C. Stable until the expiration date printed on the label.
• Opened Vials: Stable for 90 days at 2-8°C when stored closed and free from contamination.

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.