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Transplant therapeutic drug monitoring assays, such as Sirolimus and Tacrolimus, as well as Cyclosporine, are used as an aid in the management of allograft recipients receiving immunosuppressive drug (ISD) therapy.

Therapeutic drug monitoring (TDM) of transplant patients provides unique challenges to the laboratory due to the various immunosuppressive drug combinations that are prescribed. For the treatment to be optimal, clinicians need an accurate determination of a patient’s immunosuppressive drug concentration in whole blood.


Organ transplant waiting list

The number of solid organ transplant procedures performed is limited by organ availability. The waiting list grows every year.

Every ten minutes, someone is added to the national transplant waiting list.
On average, 22 people die each day while waiting for a transplant. 1

1 https://optn.transplant.hrsa.gov/ accessed January 23, 2017

Low dose therapies

The best patient outcomes seem to be achieved by maintaining the right balance of a combination of ISDs (cocktail therapy) at lower dosage levels to reduce toxicity and prevent graft loss.

Accurate and precise measurement of tacrolimus concentration, followed by optimal tacrolimus dosing, could improve patient quality of life and ensure long term survival of both the patient and allograft by reducing drug toxicity while maintaining adequate immunosuppression during low dose therapy.

 Current challenges for the laboratory

Sensitivity and accuracy



The value of architect tacrolimus2

The automated ARCHITECT Tacrolimus Assay offers the ease of use laboratories need, the turnaround time clinicians require, all with the low-end assay sensitivity and performance required for post-transplant patient therapeutic drug monitoring.

Better detection
  • First Immunoassay that meets European Consensus recommendation of 1 ng/mL or lower for LOQ
Improved accuracy and precision:
Better reliability
  • The ARCHITECT assay is both accurate and precise at low concentrations of tacrolimus between labs
Better predictability
  • Pre-treatment removes interfering substances
Lab-to-lab consistency: 
Better comparability
  • Correlates well with LC-MS/MS methods and provides consistent and timely results across labs worldwide

2 ARCHITECT Tacrolimus Package Insert 607-018 7/15/ R10 September 2015

With architect, you should be capable of implementing a best in class tacrolimus assay with a total %cv of 6-8% at low trough concentrations (3-5ng/ml).


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