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Test Name:
Fondaparinux Sodium Assay


  • SBMF No:
    25086
  • Performance Lab Name:
    Hem-Coag
  • Test Mnemonic:
    FONDAPAR
  • ABN:
    Required – "Research Use Only"
  • CPT Code:
    85130
  • LOINC Code:
    49060-7
  • Also Known As:
    Arixtra® Monitoring
    Anti-Factor Xa for Fondaparinux (Arixtra®) Monitoring
  • Spec Type:
    Platelet-poor plasma (PPP)
  • Spec Container:
    Light blue top (3.2% buffered sodium citrate) tube
  • Pref Vol:
    2.0 mL (Two aliquots, 1.0 mL each)
  • Fasting:
    No
  • Spec Collect:
    Routine venipuncture
    • NOTE: Traumatic puncture invalidates sample for coagulation studies and necessitates recollection
    • Observe proper collection order for coagulation tests; collect tubes for coagulation studies prior to collecting tubes containing clot activators, additives, or anticoagulants
    • Fill light blue top tube to stated tube volume
    • If coagulation study is only test ordered, collect 1.0 to 2.0 mL blood into tube for discard, then collect light blue top coagulation study tube(s)
    • If multiple coagulation studies are requested, submit additional samples for each coagulation test
    • Immediately after collection, gently invert tube to mix
  • Spec Process:
    Separate plasma from cells immediately
    • Promptly centrifuge 15 minutes
    • Carefully transfer plasma portion of sample to separate plastic tube using plastic pipette
    • NOTE: Buffy coat layer of sample must be avoided
    • Centrifuge transferred plasma sample again to produce platelet-poor plasma (PPP)
    • Use second plastic pipette to carefully transfer PPP sample into plastic aliquot tubes
    • Immediately freeze PPP samples
  • Spec Store Transport:
    Frozen
  • Spec Stability:
    4 hours room temperature (20-30°C)
    2 weeks frozen (-20°C) – Do not use frost free units that undergo repeated freeze/thaw cycles
  • Spec Reject:
    Citrate tube underfilled
    Sample clotted or hemolyzed
    Plasma not frozen within 4 hours of collection
  • Spec Remarks:
    Platelet-poor plasma (PPP) samples obtained by double centrifugation are critical for accurate coagulation studies as platelet contamination may cause spurious results
  • Methodology:
    Anti-Xa Chromogenic
  • Use:
    Monitor Arixtra® concentration in patients
  • Clinical Significance:
    Arixtra®, fondaparinux sodium, is a synthetic selective inhibitor of factor Xa. The drug has been approved for thromboprophylaxis after major orthopedic surgery. Although clinical monitoring with plasma Arixtra concentrations is not necessary for most patients due to low inter and intra-subject variability in the pharmacokinetics of fondaparinux, monitoring of select patient population may be desired based on the experience obtained from monitoring patients with low molecular weight heparin.
  • Reference Range:

    Fondaparinux (Arixtra) Dosage/Reference Range

    ADULT:
    Daily Dose
         		Pre-dose
    (Trough)
      mg/L (ug/mL)      		3 hrs Post-dose
    (Peak)
      mg/L (ug/mL)  
    2.5 mg
    5.0-10.0 mg       		0.14-0.19
    0.46-0.62    		0.39-0.50
    1.20-1.26

    PEDIATRIC:
    Savety and effectiveness for pediatric patients has not been established.

  • Additional Test Info:
    A reagent that is designated by the manufacturer as “for research use” was used for this test. Its performance was established and confirmed by the SBMF. This test is not cleared or approved by the U.S. FDA. The results are not intended to be used as the sole means for clinical diagnosis and patient monitoring. The South Bend Medical Foundation is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
  • Day Run:
    Mon-Fri
  • Time Run:
    7:00 am
  • Time Reported:
    5:00 pm
  • Test Type:
    COAGULATION

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