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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay.

Pierre Wallemacq¹, Jean-Sebastien Goffinet, Susan O'Morchoe

¹Cliniques universitaires St. Luc, Université catholique de Louvain, 10 Hippocrate Avenue, Brussels, Belgium. pierre.wallemacq@uclouvain.be

Therapeutic Drug Monitoring

|March 5, 2009

Summary

The Abbott ARCHITECT Tacrolimus immunoassay demonstrates robust analytical performance, offering a sensitive and reliable method for monitoring tacrolimus levels in transplant patients. This assay meets European guidelines for tacrolimus quantification, providing an alternative to LC-MSMS.

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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

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Published on: May 29, 2020

Area of Science:

Clinical Chemistry
Immunology
Pharmacology

Background:

Tacrolimus is a critical immunosuppressant drug used in organ transplantation.
Accurate monitoring of tacrolimus blood concentrations is essential for optimizing therapeutic efficacy and minimizing toxicity.
Existing analytical methods may have limitations in sensitivity or accessibility for some laboratories.

Purpose of the Study:

To evaluate the analytical performance of the Abbott ARCHITECT Tacrolimus immunoassay.
To assess the assay's accuracy, precision, and interference potential.
To compare the ARCHITECT assay with established methods like LC-MSMS.

Main Methods:

The Abbott ARCHITECT Tacrolimus assay was evaluated in 6 clinical laboratories using proficiency panels and patient specimens.
Whole blood samples underwent a methanol/zinc sulfate pretreatment.
The immunoassay involved anti-tacrolimus antibody-coated paramagnetic microparticles and an acridinium-tacrolimus tracer.

Main Results:

The assay showed low coefficient of variations (2.9%-8.2%) across different concentrations.
Limit of quantification (LOQ) ranged from 0.69 to 1.07 ng/mL, meeting the European Consensus Conference recommendation of ~1 ng/mL.
Minimal interference was observed from hematocrit, lipids, bilirubin, protein, and uric acid.
Method comparison studies showed high correlation (Spearman's rho >=0.90) with IMx, Dade Dimension, and LC-MSMS methods, with acceptable biases.

Conclusions:

The Abbott ARCHITECT Tacrolimus assay is a semiautomated, robust, and highly sensitive immunoassay.
It provides accurate and precise quantification of tacrolimus, suitable for routine clinical use.
The assay serves as a viable alternative for laboratories lacking LC-MSMS capabilities, meeting critical performance standards for tacrolimus monitoring.