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Tacrolimus

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Tacrolimus is one of the most frequently used immunosuppressive drugs in solid organ transplants.1 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.2

Therapeutic drug monitoring (TDM) of transplant patients provides unique challenges to the laboratory due to the various immunosuppressive drug combinations that are prescribed. Due to the large intra- and inter-individual  variability in pharmacokinetic factors, clinicians need an accurate determination of a patient’s immunosuppressive drug concentration in whole blood for the treatment to be optimal.2

For in vitro diagnostic use.

 

Global Demand of Transplants

Worldwide, the demand for solid organ transplants increased 9.1% versus 2021. About 18 transplants per hour were performed in 2022.3

The value of Abbott's Tacrolimus assay

The Alinity and ARCHITECT Tacrolimus assay offers the ease of use laboratories need and the turnaround time clinicians require. All with the low-end assay sensitivity and performance required for post-transplant patient therapeutic drug monitoring.4,5

Excellent precision and
high sensitivity

  • Meets European Consensus recommendation of 1 ng/mL or lower for LOQ.6
  • The assay is both accurate and precise at low concentrations of tacrolimus between labs

Minimal Interference: Better predictability 

  • Pre-treatment reduces interfering substances

Lab-to-lab consistency: Better comparability 

  • Correlates well with LC-MS/MS methods and provides consistent and timely results across labs worldwide6,7

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References
  1. Brunet at al., Therapeutic Drug Monitoring of Tacrolimus-Personalized Therapy: Second Consensus Report. Therapeutic Drug Monitoring 41(3):p 261-307, June 2019. 
  2. Kang JS, Lee MH. Overview of therapeutic drug monitoring. Korean J Intern Med. 2009 Mar;24(1):1-10. doi: 10.3904/kjim.2009.24.1.1. PMID: 19270474.
  3. https://www.transplant-observatory.org. Accessed March 12, 2024. 
  4. ARCHITECT Tacrolimus Package Insert 607-018 7/15/ R10 September 2015. 
  5.  Alinity i Tacrolimus Package Insert 711-327_R03 August 2019.
  6. Wallemacq P et al., Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay. Ther Drug Monit. 2009 Apr;31(2):198-204. doi: 10.1097/FTD.0b013e31819c6a37. PMID: 19258928.
  7. Woodard, K & Kisler, T & Dasgupta, A. (2023). B-303 Comparison of Tacrolimus Concentrations Obtained By the Newly Approved Alinity i Tacrolimus Assay With a Reference Liquid-Chromatography Combined With Tandem Mass spectrometry Assay. Clinical Chemistry. 69. 10.1093/clinchem/hvad097.623.
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All ARCHITECT analyzers, Alinity hq, CELL-DYN Ruby and CELL-DYN Emerald 22 AL instruments are Class I laser products. ACCELERATOR APS and ACCELERATOR a3600 are Class II laser products.

The Alinity, ARCHITECT and CELL-DYN systems are intended for performing in vitro diagnostic assays on samples of human origin. Read the instructions in the system manuals and labeling and/or reagent instructions carefully.

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