Study of Tacrolimus Calibrator and Reagent Matrix Effect

A specific drug concentration in the blood must be maintained for tacrolimus, which controls immune rejection in organ transplant patients. Therefore, monitoring it through accurate tests is important to confirm this level. This paper reports a case in which the quality control results differed acco...

Full description

Saved in:
Bibliographic Details
Main Author: Haeyong JUNG
Format: Article
Language:English
Published: The Korean Society for Clinical Laboratory Science 2025-03-01
Series:Korean Journal of Clinical Laboratory Science
Subjects:
Online Access:http://www.kjcls.org/journal/view.html?doi=10.15324/kjcls.2025.57.1.88
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850095223782244352
author Haeyong JUNG
author_facet Haeyong JUNG
author_sort Haeyong JUNG
collection DOAJ
description A specific drug concentration in the blood must be maintained for tacrolimus, which controls immune rejection in organ transplant patients. Therefore, monitoring it through accurate tests is important to confirm this level. This paper reports a case in which the quality control results differed according to the calibrator and reagent in the tacrolimus test. This laboratory performs a tacrolimus (FK-506) test using the Alinity I system. Multichem WBT was used as a quality control material. Quality control materials were installed in the equipment within 30 minutes of manual pretreatment. A comparison of the quality control results of calibrator lot number 46248FP00 and reagent lot number 46243FP00 with calibrator lot number 46248FP00 and reagent lot number 50450FP00 revealed a 16% difference in values between calibrator lot number 46248FP00 and reagent lot number 50450FP00. These results were attributed to differences between the reagents and calibration materials. Hence, manufacturers and laboratories need to prepare for this.
format Article
id doaj-art-c1b2b803a28541de96d54ec96753c512
institution DOAJ
issn 1738-3544
language English
publishDate 2025-03-01
publisher The Korean Society for Clinical Laboratory Science
record_format Article
series Korean Journal of Clinical Laboratory Science
spelling doaj-art-c1b2b803a28541de96d54ec96753c5122025-08-20T02:41:30ZengThe Korean Society for Clinical Laboratory ScienceKorean Journal of Clinical Laboratory Science1738-35442025-03-01571889310.15324/kjcls.2025.57.1.88kjcls.2025.57.1.88Study of Tacrolimus Calibrator and Reagent Matrix EffectHaeyong JUNG0Department of Laboratory Medicine, Soon Chun Hyang University Seoul Hospital, Seoul, KoreaA specific drug concentration in the blood must be maintained for tacrolimus, which controls immune rejection in organ transplant patients. Therefore, monitoring it through accurate tests is important to confirm this level. This paper reports a case in which the quality control results differed according to the calibrator and reagent in the tacrolimus test. This laboratory performs a tacrolimus (FK-506) test using the Alinity I system. Multichem WBT was used as a quality control material. Quality control materials were installed in the equipment within 30 minutes of manual pretreatment. A comparison of the quality control results of calibrator lot number 46248FP00 and reagent lot number 46243FP00 with calibrator lot number 46248FP00 and reagent lot number 50450FP00 revealed a 16% difference in values between calibrator lot number 46248FP00 and reagent lot number 50450FP00. These results were attributed to differences between the reagents and calibration materials. Hence, manufacturers and laboratories need to prepare for this.http://www.kjcls.org/journal/view.html?doi=10.15324/kjcls.2025.57.1.88matrix effect; tacrolimus; therapeutic drug monitoring
spellingShingle Haeyong JUNG
Study of Tacrolimus Calibrator and Reagent Matrix Effect
Korean Journal of Clinical Laboratory Science
matrix effect; tacrolimus; therapeutic drug monitoring
title Study of Tacrolimus Calibrator and Reagent Matrix Effect
title_full Study of Tacrolimus Calibrator and Reagent Matrix Effect
title_fullStr Study of Tacrolimus Calibrator and Reagent Matrix Effect
title_full_unstemmed Study of Tacrolimus Calibrator and Reagent Matrix Effect
title_short Study of Tacrolimus Calibrator and Reagent Matrix Effect
title_sort study of tacrolimus calibrator and reagent matrix effect
topic matrix effect; tacrolimus; therapeutic drug monitoring
url http://www.kjcls.org/journal/view.html?doi=10.15324/kjcls.2025.57.1.88
work_keys_str_mv AT haeyongjung studyoftacrolimuscalibratorandreagentmatrixeffect