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Test Code:
090-30-1392-01

Order Name:
Rapamune (Sirolimus) 

 
Useful For:
Determination of sirolimus in human whole blood.

Sirolimus assay is to be used as an aid in the management of renal transplant patients receiving sirolimus therapy.
 
Methodology:
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
AliasesName:
Rapamune 
Sirolimus
 
 
 
Test Code:
090-30-1392-01

Order Name:
Rapamune (Sirolimus) 

 
Collection Specimen Or Container:
Blood/ K3 EDTA (Lavender Top) 3 mL, 1 tube
 
Specimen Testing Type:
EDTA Whole blood, minimum volume 1 mL
 
Sub Mission Container:
Plastic vial
 
Specimen Stabillity:
Specimen Type Temperature Time
EDTA whole blood Refrigerated, 2oC to 8oC 7 days
Frozen, -10oC 14 days
 
 
 
Test Code:
090-30-1392-01

Order Name:
Rapamune (Sirolimus) 

 
Method detail:
Chemiluminescent Microparticle Immuno Assay (CMIA)
 
Schedule:
Tested Daily (24 Hours)
 
Turnaround Time:
Specimen collected to reported within 3:00 Hours (180 Mins)
 
Performing Location:
Immunology, Laboratory Department Tel. 13227
 
Specimen Retention Time:
5 days
 
 
 
Test Code:
090-30-1392-01

Order Name:
Rapamune (Sirolimus) 

 
 
Clinical Information:
Sirolimus (Rapamune, rapamycin, Wyeth Pharmaceuticals, Collegeville, PA) is an immunosuppressive drug for renal transplant immunosuppressive therapy. The safety and efficacy of sirolimus in helping prevent tissue rejection was initially demonstrated in two multicenter trials (Trials 301 and 302) involving postrenal transplant patients receiving full-dose cyclosporine and corticosteroids. The data indicated beneficial prophylaxis against
acute rejection from sirolimus therapy in conjunction with cyclosporine and corticosteroids. Subsequently, the safety and efficacy of sirolimus as a maintenance regimen following cyclosporine withdrawal was assessed.

In this study, clinical outcomes of patients withdrawn from cyclosporine and maintained on sirolimus and corticosteroids compared favorably to patients continuing on the triple-drug immunosuppressive regimen. Because of potential toxic effects associated with high trough levels of sirolimus, therapeutic drug monitoring of sirolimus immunosuppressive therapy has been recommended. Pharmacokinetic studies indicate that sirolimus
is primarily sequestered in erythrocytes, and that the appropriate sample medium with which to monitor sirolimus is whole blood.
 
Reference Value:
Trough level: 5 – 15 ng/mL
 
Clinical Reference:
  1. Manufacturer’s Reagent package insert, Sirolimus, September 2015 , Abbott Laboratories, MAX-Planck-Ring 65205 Wiesbaden, Germany.
  2. Reference intervals: UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com (Retrieved: July2018)