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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
[Performance evaluation of affinity column mediated immunometric assay for tacrolimus]
Jae Woo Chung1, Dongheui An, Junghan Song
1Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
The Korean Journal of Laboratory Medicine
|November 7, 2009
Summary
This study validates the Affinity Column Mediated Immunometric Assay (ACMIA) for tacrolimus monitoring. The ACMIA demonstrates suitable performance for clinical use, offering faster results for transplant patient management.
Area of Science:
- Clinical Chemistry
- Immunology
- Pharmacology
Background:
- Therapeutic drug monitoring (TDM) of tacrolimus is crucial due to its narrow therapeutic index.
- Tacrolimus dose-response variability necessitates precise blood concentration measurements.
- Affinity Column Mediated Immunometric Assay (ACMIA) offers a pretreatment-free method for tacrolimus quantification.
Purpose of the Study:
- To evaluate the analytical performance of a novel tacrolimus assay utilizing ACMIA.
- To assess the assay's precision, linearity, detection limits, and interference profile.
- To compare the ACMIA tacrolimus assay with established methods like MEIA and LC-MS/MS.
Main Methods:
- Assessed imprecision, linearity, and detection limits following CLSI guidelines (EP5-A2, EP6-A, EP17-A).
- Evaluated interferences from bilirubin and chyle, and correlation with hematocrit (EP7-A2, EP9-A2).
- Conducted method comparison studies against microparticle enzyme immunoassay (MEIA) and liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Main Results:
- Total imprecision ranged from 6.7% to 12.8% across different concentration levels.
- Demonstrated clinically relevant linearity from 3.1 ng/mL to 35.4 ng/mL.
- Showed good correlation with MEIA (r=0.950) and LC-MS/MS (r=0.946), with no significant interferences or hematocrit correlation.
Conclusions:
- The ACMIA tacrolimus assay meets clinical requirements for imprecision, linearity, detection limits, and interference.
- This assay can reduce turnaround time, aiding in the management of transplant patients.
- ACMIA provides a reliable method for therapeutic drug monitoring of tacrolimus.
