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Test Name:
Sirolimus, Whole Blood


  • SBMF No:
    30064
  • Performance Lab Name:
    Toxicology
  • Test Mnemonic:
    SIROLIMUS
  • ABN:
    Not required
  • CPT Code:
    80195
  • LOINC Code:
    29247-4
  • Also Known As:
    Rapamune®
    Rapamycin®
    Immunosuppressant
  • Spec Type:
    Whole blood
  • Spec Container:
    Lavender top (EDTA) tube
  • Pref Vol:
    0.5 mL
  • Min Vol:
    0.2 mL
  • Fasting:
    No
  • Spec Collect:
    Routine venipuncture
    Label specimen with time of collection and time of last drug administration
  • Spec Process:
    Do not centrifuge
    Do not remove plasma from cells
  • Spec Store Transport:
    Refrigerated
  • Spec Stability:
    1 week refrigerated (2-8C)
    2 weeks frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles
  • Spec Reject:
    Sample other than EDTA whole blood
  • Methodology:
    Liquid Chromatography/Tanden Mass Spectrometry (LC/MS.MS)
  • Use:
    Aid in management of renal transplant patients receiving Sirolimus immunosuppressive treatment
  • Clinical Significance:
    Sirolimus (Rapamune®, Rapamycin®) is an immunosuppressive drug used for renal transplant immunosuppressive therapy. Sirolimus is a macrocyclic lactone fermentation product of Streptomyces hygroscopicus. It exhibits a synergistic action with calcineurin inhibitors. It binds to the immunophillin FK-binding protein 12, and the resulting complex binds to a specific cell-cycle regulatory protein mTOR and inhibits its activation. The inhibition of mTOR results in suppression of cytokine-driven T-lymphocyte proliferation, inhibiting the progression from G1 to the S phase of the cell cycle.A good correlation of trough concentration to area under the concentration time curve (AUC) was found and a strong correlation between the evidence of toxicity and high trough concentrations has been reported. Therefore, trough concentration measurement provides a useful index of total drug exposure during the dosing interval.Sirolimus results measured by MEIA were found to be higher than those reported by the previous method, High Performance Liquid Chromatography (HPLC).The following correlation statistics were observed by studying over 200 renal transplant patients who were under Sirolimus treatment: MEIA = 1.232(HPLC) – 0.28 r = 0.929
  • Reference Range:
    Therapeutic range: 5.0-15.0 ng/mL
  • Day Run:
    Mon-Fri
  • Time Reported:
    Next day
  • Test Type:
    TOX-TDM

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