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Immunosuppressive Drug Measurement by Liquid Chromatography Coupled to Tandem Mass Spectrometry: Interlaboratory Comparison in the Korean Clinical Laboratories

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Abstract
Background: Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) is increasingly used for immunosuppressive drug tests. However, most LC-MS/MS tests are laboratory-developed and their agreement is unknown in different Korean laboratories. This interlaboratory comparison study evaluated test reproducibility and identified potential error sources.

Methods: Test samples containing three concentrations of tacrolimus, sirolimus, everolimus, cyclosporine, and mycophenolic acid were prepared by pooling surplus samples from patients undergoing routine therapeutic drug monitoring and tested in duplicate in the participating 10 clinical laboratories. Reconstitution and storage experiments were conducted for the commonly used commercial calibrator set. The robust estimators of reproducibility parameters were calculated. Spearman's rank correlation coefficient (rho, rho) was used to evaluate the correlation between drugs. Multiple linear regression was used to determine whether the experimental conditions alter the calibration curves.

Results: The reproducibility coefficient of variation exceeded 10% only for sirolimus concentrations 1 and 2 (10.8% and 12.5%, respectively) and everolimus concentrations 1 and 2 (12.3% and 11.4%, respectively). The percent difference values showed weak correlations between sirolimus and everolimus (rho=0.334, P=0.175). The everolimus calibration curve slope was significantly altered after reconstitution following prolonged 5 degrees C storage (P=0.015 for 14 days; P=0.025 for 28 days); the expected differences at 6 ng/mL were 0.598% for 14 days and 0.384% for 28 days.

Conclusions: LC-MS/MS test reproducibility for immunosuppressive drugs seems to be good in the Korean clinical laboratories. Continuous efforts are required to achieve test standardization and harmonization, especially for sirolimus and everolimus.
Author(s)
김현기박형두이상국채효진송상훈이용화윤여민안선현김세림이선민이수연전사일
Issued Date
2021
Type
Article
Keyword
Immunosuppressive drugTherapeutic drug monitoringLiquid chromatography coupled to tandem mass spectrometryInterlaboratory comparisonSirolimusEverolimusReproducibility INTRODUCTION
DOI
10.3343/alm.2021.41.3.268
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8577
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_nrf_kci_oai_kci_go_kr_ARTI_9791050&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Immunosuppressive%20Drug%20Measurement%20by%20Liquid%20Chromatography%20Coupled%20to%20Tandem%20Mass%20Spectrometry:%20Interlaboratory%20Comparison%20in%20the%20Korean%20Clinical%20Laboratories&offset=0&pcAvailability=true
Publisher
ANNALS OF LABORATORY MEDICINE
Location
대한민국
Language
영어
ISSN
2234-3806
Citation Volume
41
Citation Number
3
Citation Start Page
268
Citation End Page
276
Appears in Collections:
Medicine > Medicine
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