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...
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| Format: | Article |
| Language: | English |
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The Korean Society for Clinical Laboratory Science
2025-03-01
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| Series: | Korean Journal of Clinical Laboratory Science |
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| Online Access: | http://www.kjcls.org/journal/view.html?doi=10.15324/kjcls.2025.57.1.88 |
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| 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 |