Evaluation of the Architect® tacrolimus assay in kidney, liver, and heart transplant recipients

Bazin, Christophe; Guinedor, Amélie; Barau, Caroline; Gozalo, Claire; Grimbert, Philippe; Duvoux, Christophe; Furlan, Valérie; Massias, Laurent; Hulin, Anne

doi:10.1016/j.jpba.2010.06.022

Cited by 46 publications

(29 citation statements)

References 21 publications

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“…Immunoassay results were overestimated compared to LC-MS/MS by a mean of 18.1% for tacrolimus, 41.4% for sirolimus, and 15.6% for cyclosporine ( Fig. 3D-F), which is comparable to previously published biases for the Abbott Architect chemiluminescent immunoassays [22][23][24][25]. …”

Section: Correlation With Immunoassayssupporting

confidence: 85%

Successful and cost-efficient replacement of immunoassays by tandem mass spectrometry for the quantification of immunosuppressants in the clinical laboratory

Hétu

Robitaille

Vinet

2012

Journal of Chromatography B

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Section: Correlation With Immunoassayssupporting

confidence: 85%

Successful and cost-efficient replacement of immunoassays by tandem mass spectrometry for the quantification of immunosuppressants in the clinical laboratory

Hétu

Robitaille

Vinet

2012

Journal of Chromatography B

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“…After an overnight fast, patients' morning tacrolimus dose was administered in capsules, and serial blood samples were drawn over the course of the dosing interval at times 0 (predose), and 0.5, 1, 2, 4, 6, 8, and 12 h postdose. EDTA whole-blood samples were analyzed either fresh at room temperature or after being frozen at Ϫ80°C via whole-blood immunoassay [Architect tacrolimus in whole blood (Bazin et al, 2010), Mayo Clinic Arizona, Phoenix, AZ].…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetic Differences Corroborate Observed Low Tacrolimus Dosage in Native American Renal Transplant Patients

et al. 2011

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ABSTRACT:We have observed in clinical practice that Native Americans require lower dosages of tacrolimus to attain similar target blood trough levels compared to whites after renal transplant. Because there are no pharmacokinetic studies of tacrolimus in this ethnic group, we investigated whether this clinical observation could be corroborated by pharmacokinetic differences between Native Americans and other ethnic and racial groups. We recruited 24 adult Native American kidney transplant recipients on stable oral doses of tacrolimus for at least 1 month posttransplant. We conducted a 12-h steady-state pharmacokinetic profile for all of the patients and estimated pharmacokinetic parameters using NON-MEM. The concentration-time data were fit to a linear two compartment model with first-order absorption and lag time using an empirical Bayesian approach. The mean estimate of oral clearance (CL/F) was 11.1 l/h. Compared with previously reported data in other ethnic and racial groups, the Native American cohort has approximately one third the clearance of other groups. Our pharmacokinetic study reveals the clinically observed low dose of tacrolimus in Native American renal transplant patients is associated with a decreased oral tacrolimus clearance. There is scant information available on the genetic or environmental characteristics unique to this ethnic group that affect pharmacokinetics compared to other, better-studied groups, and elucidation of these factors will provide information to further facilitate individualized drug treatment for tacrolimus and a wide range of other drugs with similar clearance processes.

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“…6,9,11) The 20% CV values for ACMIA on 19 different Dimension ® analyzers in the present study were slightly lower than the reported LOQ values. 6,9,11) Although the linearity for ACMIA is reported to be up to at least 31.4 ng/ mL, 11) ACMIA tended to have a negative bias at higher tacrolimus concentrations. The present results completely agree with the previous report using spiked samples by Levine et al 12) In addition, Hashi et al 13) also reported that the ME for ACMIA at tacrolimus concentrations greater than 10 ng/mL has a more negative bias.…”

Section: Discussionmentioning

confidence: 96%

“…LOQ values for CLIA and ECLIA are reported to be 0.5-0.8 [6][7][8][9] and 0.2-0.3 ng/mL, 10) respectively. These LOQ values were calculated by Architect ® analyzer or cobas ® analyzer On the other hand, the LOQ value for ACMIA is reported to be 2.5-3.12 ng/mL.…”

Section: Discussionmentioning

confidence: 99%

Inter-laboratory Variability of Current Immunoassay Methods for Tacrolimus among Japanese Hospitals

Miura

Masuda

Egawa

et al. 2016

Biological & Pharmaceutical Bulletin

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The aim of this study was to assess inter-hospital laboratory variability (coefficient of variation; CV) of immunoassay methods for tacrolimus and the comparability of control samples and results obtained by immunoassay measurements. One hundred seven hospital laboratories routinely performing therapeutic drug monitoring (TDM) of tacrolimus participated in the study. Thirteen spiked samples with known tacrolimus concentrations in the range of 0-26.0 ng/mL were prepared. Each spiked sample was analyzed according to the manufacturer's instructions using an affinity column-mediated immunoassay (ACMIA) on a Dimension ® analyzer, the enzyme multiplied immunoassay technique (EMIT) on a Viva-E ® analyzer, a chemiluminescent enzyme immunoassay (CLIA) on the Architect ® system, and the electro-chemiluminescence immunoassay (ECLIA) on a cobas ® analyzer. The 20% coefficient of variation values for the CLIA, ACMIA, EMIT, and ECLIA assays in the hospital laboratories were 1.82, 5.36, 4.59, and 0.89 ng/mL, respectively. CLIA and ECLIA had positive biases at concentrations of tacrolimus above 12 ng/mL relative to the spiked concentration, whereas the assay bias for ACMIA tended to be more negative at concentrations of tacrolimus above 6 ng/mL. EMIT had positive biases over the wide concentration range of 0.0-26.0 ng/mL (mean of mean errors 1.224). CLIA and ECLIA provided adequate precision at the target tacrolimus concentration of 3.0 ng/ mL, whereas ACMIA and EMIT were unable to respond to target concentrations between 3.0 and 5.0 ng/ mL for renal transplant recipients. Appropriate assessment of tacrolimus concentration by an assay having higher sensitivity, precision, and accuracy is necessary to ensure long-term survival of transplant recipients receiving tacrolimus.

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Evaluation of the Architect® tacrolimus assay in kidney, liver, and heart transplant recipients

Cited by 46 publications

References 21 publications

Successful and cost-efficient replacement of immunoassays by tandem mass spectrometry for the quantification of immunosuppressants in the clinical laboratory

Successful and cost-efficient replacement of immunoassays by tandem mass spectrometry for the quantification of immunosuppressants in the clinical laboratory

Pharmacokinetic Differences Corroborate Observed Low Tacrolimus Dosage in Native American Renal Transplant Patients

Inter-laboratory Variability of Current Immunoassay Methods for Tacrolimus among Japanese Hospitals

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