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Test Code EVERB Everolimus

Specimen and Container/Tube

Specimen Type: Whole Blood

Preferred Specimen: EDTA Lavender Top

Other Acceptable specimens: N/A

Specimen Handling and Transport Instructions

UCMC Onsite Instructions: 

Collect specimen per standard collection procedure immediately before scheduled dose and send to laboratory immediately.

 

UCMC Offsite and UC MedLab Outreach Instructions: 

  • Samples must be sent room temperature at 15-25oC if transporting samples within 2 hours.
  • Refrigerate for longer transport time.

Rejection Criteria

  • Common specimen rejected situations include: incorrect specimen type, insufficient volume, missing or incomplete specimen identifiers, incorrect specimen transport, or specimens outside stability limits. 
  • Specimens that are clotted.

Reference Values

 

Test

Age

Sex

Reference Range
      Trough Peak

Everolimus

All

All

3-8 ng/mL

N/A
  • Therapeutic (reference) ranges for immunosuppressant drugs have generally not been well established, as they tend to vary depending upon type of transplant, patient clinical status and post-transplantation duration/course, concomitant use of other pharmacologic agents of the same class, the dosing/collection intervals and other known factors. The stated range is based upon commonly published guidelines, and any results are subject to physician interpretation and should be used in conjunction with other diagnostic and clinical information. 
  • Everolimus marketed as Afinitor is FDA approved for the treatment of renal cell carcinoma and for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) in patients who are not candidates for curative surgical resection. The suggested therapeutic range for treatment of SEGA is 5-10 ng/mL, which is based on a predose (trough) specimen.

Critical Values

Analyte

Unit

Low

High

Age

N/A

N/A

N/A

N/A

N/A

CPT Codes

80169

Volume

Preferred Volume: 4.0 mL

Minimum Volume: 0.2 mL

Specimen Stability

Storage Temperature

Stability

Room temperature

7 days

Refrigerated

7 days

Frozen

30 days

Collection Instructions

Collect specimen per standard laboratory collection procedures immediately before scheduled dose.

 

Test Components

Everolimus

Clinical Indications

Monitoring whole blood everolimus concentration during therapy.

Methodology

Liquid Chromatography/Mass Spectometry (LC-MS/MS) (Thermo Fisher Scientific)

Additional Information

  • Results should always be assessed in conjunction with patient's medical history, clinical examination and other findings. 
  • The recommended therapeutic range applies to trough specimens drawn immediately before a dose. Blood drawn at other times will yield higher results.
  • This test was developed and its performance characteristics validated by the UCH Section of Clinical Chemistry.  It has not been approved by the FDA.
  • The UCH Section of Clinical Chemistry is regulated under CLIA and is qualified to perform high complexity testing.  This test should only be used for clinical purposes and should not be regarded as investigational or for research.
  • Results obtained by LC-MS/MS.

Turnaround Time

Turnaround times are relative to the time the specimen is received in the test laboratory. 

 

STAT Turnaround Time: Not available as STAT test

Routine Turnaround Time: 4 hours

Testing Schedule: Monday – Friday (7am – 3pm), Saturday & Sunday (7am – 9am)

Last Review Date

6/12/23