Comparison of whole‐blood tacrolimus concentrations measured by different immunoassay systems

Kaneko, Tetsuya; Fujioka, Takashi; Suzuki, Yosuke; Nagano, Takayuki; Sato, Yuhki; Asakura, Syunji

doi:10.1002/jcla.22587

Cited by 11 publications

(7 citation statements)

References 7 publications

(9 reference statements)

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“…Comparative data in our laboratory showed a good correlation between LC–MS/MS and CMIA (Figure 5A–D). However, the correlation coefficient (0.7581) at month 1 was lower, but the overall correlation coefficient observed in this study was comparable with previously reported studies 27,28 . In addition, Passing–Bablok regression analysis demonstrated good correlations with r 2 values higher than 0.88 between TAC levels measured by LC–MS/MS and CMIA for all three time points (Table 9 and Figure 4).…”

Section: Discussionsupporting

confidence: 90%

“…However, the correlation coefficient (0.7581) at month 1 was lower, but the overall correlation coefficient observed in this study was comparable with previously reported studies. 27,28 In addition, Passing-Bablok regression analysis demonstrated good correlations with r 2 values higher than 0.88 between TAC levels measured by LC-MS/MS and CMIA for all three time points (Table 9 and Figure 4). Bland-Altman plots gave positive biases of 1.29 ng/mL in samples at 1 month (Figure 6A), 0.79 ng/mL at 3 months (Figure 6B), and 0.65 ng/mL at all time points (Figure 6D).…”

Section: Discussionmentioning

confidence: 78%

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Determination of tacrolimus in human whole blood in kidney transplant recipients using a rapid and specific LC–MS/MS method

Hieu,

Dung,

Toan

et al. 2023

Clinical Laboratory Analysis

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ObjectiveTo develop and validate an LC‐M/SMS method for the determination of tacrolimus in human whole blood.MethodThe LC–MS/MS method for the determination of tacrolimus in whole blood was developed and validated according to the guidelines. Concentrations of TAC in 100 kidney transplant patients measured by LC–MS/MS were compared with CMIA using correlation analysis and Bland–Altman plots.ResultsThe method had a total chromatographic run time of 5 min. The calibration curves were linear over the range of 0.5–100.0 ng/mL with a lower limit of quantification of 1 ng/mL. The intra‐ and interday accuracy was within the range of 93.3%–109.2% and 96.0%–108.4%, respectively, with precision ranging from 0.8 to 9.4%. The mean extraction recoveries of TAC ranged from 102.6 to 107.8%. The mean concentrations of TAC in whole blood of kidney transplant patients measured by the two assays were different at 1, 3 months and all time points (p < 0.001), but no significant difference was observed at 6 months (p = 0.094). The correlation of data was good with the correlation coefficients (r2) of 0.7581, 0.8811, 0.8777, and 0.8077, respectively. Passing–Bablok regression analysis demonstrated good correlations with r2 values higher than 0.88 between TAC levels measured by LC–MS/MS and CMIA. Using Bland–Altman plots yielded average biases of 1.29, 0.79, 0.11, and 0.65 ng/mL at 1, 3, and 6 months and all time points.ConclusionThe LC–MS/MS method was validated for the accurate determination of TAC in human whole blood. The comparison of tacrolimus concentrations measured by the LC–MS/MS with CMIA showed a good correlation and agreement of two methods, suggesting LC–MS/MS should be used routinely to monitor TAC concentrations in kidney transplant patients.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 78%

Determination of tacrolimus in human whole blood in kidney transplant recipients using a rapid and specific LC–MS/MS method

Hieu,

Dung,

Toan

et al. 2023

Clinical Laboratory Analysis

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“…The therapeutic ranges of TAC and SIR are 5–10 and 4–12 ng/ml, respectively (Lee et al, 2019; Sikma et al, 2015; Zhang et al, 2018). Because of the narrow therapeutic windows and wide ranges of inter‐ and intra‐subject pharmacokinetic variability for both drugs causing serious side effects, monitoring of blood concentrations is required for optimal dose individualization (Bodnar‐Broniarczyk et al, 2019; Kaneko et al, 2018; Krnáč et al, 2019; Lee et al, 2019; Smith et al, 2003; Zhang et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

“…Routine therapeutic drug monitoring (TDM) of immunosuppressants is essential to maintain the target therapeutic range in transplant recipients (Kaneko et al, 2018; Lee et al, 2019). There are two main analytical methods for the quantitation of immunosuppressants, including automatic immunological and chromatographic methods.…”

Section: Introductionmentioning

confidence: 99%

Development of UHPLC–MS/MS method for simultaneous determination of tacrolimus and sirolimus in human whole blood and comparisons with two immunoassays

Liu

Geng

Zhao

et al. 2022

Biomedical Chromatography

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Tacrolimus (TAC) and sirolimus (SIR) antirejection medications are widely used in organ transplantation. We aimed to develop an ultra‐high performance liquid chromatography tandem mass spectrometry (UHPLC–MS/MS) assay for quantifying TAC and SIR simultaneously and evaluating agreement with chemiluminescence microparticle immunoassay (CMIA) and electrochemiluminescence immunoassay (ECLIA). Whole blood samples collected from 209 TAC and 208 SIR patients were assessed by UHPLC–MS/MS, CMIA and ECLIA. The agreement of the three techniques was assessed using the Bland–Altman plot. The UHPLC–MS/MS assay had a calibration range of 1–100 ng/ml for TAC and SIR. The accuracy and precision were −2.73–4.32% and <4.71% for TAC, respectively, and 0.07–4.84% and <6.5% for SIR, respectively. The three methods had good correlation. In comparison with UHPLC–MS/MS, two immunoassays showed a slight deviation in proportion. An UHPLC–MS/MS method for simultaneously detecting TAC and SIR in human whole blood was developed, validated and comparatively analyzed with CMIA and ECLIA. For determining TAC and SIR, immunoassays displayed acceptable analytical performances in terms of precision and correlation compared with UHPLC–MS/MS. However, further investigation is warranted to examine the novel method.

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“…Currently, tacrolimus (TAC) is among the most used first-line immunosuppressant drug for the prevention of posttransplantation graft rejection . Despite a rather good effectiveness and tolerability, this drug shows a narrow therapeutic range and quite high intraand inter-patient variability in its concentrations in whole blood (WB) (Bahmany et al, 2018;Kaneko et al, 2018;Álvarez et al, 2020). For these reasons, therapeutic drug monitoring (TDM) is particularly indicated in order to guide therapeutic adjustments during treatment, particularly in the early phase posttransplantation, and then regularly during the maintenance phase.…”

Section: Introductionmentioning

confidence: 99%

Monitoring Tacrolimus Concentrations in Whole Blood and Peripheral Blood Mononuclear Cells: Inter- and Intra-Patient Variability in a Cohort of Pediatric Patients

et al. 2021

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Tacrolimus (TAC) is a first-choice immunosuppressant for solid organ transplantation, characterized by high potential for drug-drug interactions, significant inter- and intra-patient variability, and narrow therapeutic index. Therapeutic drug monitoring (TDM) of TAC concentrations in whole blood (WB) is capable of reducing the incidence of adverse events. Since TAC acts within lymphocytes, its monitoring in peripheral blood mononuclear cells (PBMC) may represent a valid future alternative for TDM. Nevertheless, TAC intracellular concentrations and their variability are poorly described, particularly in the pediatric context. Therefore, our aim was describing TAC concentrations in WB and PBMC and their variability in a cohort of pediatric patients undergoing constant immunosuppressive maintenance therapy, after liver transplantation. TAC intra-PBMCs quantification was performed through a validated UHPLC–MS/MS assay over a period of 2–3 months. There were 27 patients included in this study. No significant TAC changes in intracellular concentrations were observed (p = 0.710), with a median percent change of −0.1% (IQR −22.4%–+46.9%) between timings: this intra-individual variability was similar to the one in WB, −2.9% (IQR −29.4–+42.1; p = 0.902). Among different patients, TAC weight-adjusted dose and age appeared to be significant predictors of TAC concentrations in WB and PBMC. Intra-individual seasonal variation of TAC concentrations in WB, but not in PBMC, have been observed. These data show that the intra-individual variability in TAC intracellular exposure is comparable to the one observed in WB. This opens the way for further studies aiming at the identification of therapeutic ranges for TAC intra-PBMC concentrations.

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Comparison of whole‐blood tacrolimus concentrations measured by different immunoassay systems

Abstract: The ACMIA and CLIA yield considerably better results than the EMIT for monitoring blood tacrolimus concentrations.

Cited by 11 publications

References 7 publications

Determination of tacrolimus in human whole blood in kidney transplant recipients using a rapid and specific LC–MS/MS method

Determination of tacrolimus in human whole blood in kidney transplant recipients using a rapid and specific LC–MS/MS method

Development of UHPLC–MS/MS method for simultaneous determination of tacrolimus and sirolimus in human whole blood and comparisons with two immunoassays

Monitoring Tacrolimus Concentrations in Whole Blood and Peripheral Blood Mononuclear Cells: Inter- and Intra-Patient Variability in a Cohort of Pediatric Patients

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