Tacrolimus, Immunoassay

Test Code
LAB6416


CPT Codes
80197

Preferred Specimen
Whole blood -  Lavender EDTA 


Minimum Volume
3.0 mL whole blood (preferred)

1.0 mL whole blood (minimum)


Other Acceptable Specimens
Pink K2 EDTA collection tubes are acceptable alternative.


Instructions
Send original tube; DO NOT CENTRIFUGE


Transport Temperature
Room Temperature


Specimen Stability
Refrigerated -  stable up to 7 days

Frozen (-10º C or colder) - stable up to 6 months.


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Serum or plasma samples should be rejected.


Methodology
Chemiluminescent Immunoassay Technology

FDA Status
Approved

Reference Range
5.0-20.0 ng/mL


Clinical Significance
Tacrolimus is an immunosuppressive drug discovered in 1984 by the Fujisawa Pharmaceutical Co., Ltd. It has been shown to be effective for the treatment of organ rejection following transplantation.  Tacrolimus may be administered IV or orally. Absorption from the gastrointestinal tract is variable and irregular.  Pharmacokinetic studies have also indicated that whole blood rather than plasma may serve as the more appropriate medium to describe the pharmacokinetic characteristics of tacrolimus. Tacrolimus is bound to proteins, mainly albumin and α-1-acid glycoprotein, and is highly bound to erythrocytes. The distribution of tacrolimus between whole blood and plasma depends on several factors such as hematocrit, temperature of separation of plasma, drug concentration, and plasma protein concentration. 

Tacrolimus is extensively metabolized in the liver and small intestine.  The use of tacrolimus is associated with nephrotoxicity.  At the present time, it is not clear whether the nephrotoxicity is the result of parent drug, metabolites, or combination of both.  Other adverse side effects include neurotoxicity, hypertension, insomnia, and nausea.


Performing Laboratory
GBMC IMMUNOLOGY/SEROLOGY



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.