The Need for Standardization of Tacrolimus Assays

Levine, Daniel M.; Maine, Gregory T.; Armbruster, David; Mussell, Christopher; Buchholz, Christoph; O’Connor, Gavin; Tuck, Victoria; Johnston, Atholl; Holt, David W.

doi:10.1373/clinchem.2011.172080

Cited by 57 publications

(37 citation statements)

References 15 publications

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“…Thus, assay calibration, sample pretreatment, and instrumentation were standardized among the participating centers. This level of platform standardization was consistent with the Abbott Architect and Siemens/Dade Dimension tacrolimus assays that were the subject of an earlier study, but differed from the variety of tacrolimus LC-MS measurement procedures used in that same study (4 ). The MassTrak assay performance characteristics have been described elsewhere (5,6 ).…”

Section: Participating Centers and Instrumentationmentioning

confidence: 55%

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Standardization of LC-MS for Therapeutic Drug Monitoring of Tacrolimus

et al. 2013

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BACKGROUND: LC-MS is increasingly used for therapeutic drug monitoring of tacrolimus. A recent summary from an international proficiency-testing scheme demonstrated that the mass spectrometry respondents were the largest method group. However, these methods lack standardization, which may explain the relatively poor interlaboratory agreement for such methods. This study aimed to provide one path toward the standardization of tacrolimus quantification by use of LC-MS.

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Section: Participating Centers and Instrumentationmentioning

confidence: 55%

“…A whole blood tacrolimus panel was prepared by Analytical Services International (ASI) 6 as previously described (4 ). Briefly, 10 patient pools (target 0 -25 ng/mL) and 10 tacrolimus-supplemented samples (target 2-25 ng/mL) were prepared in duplicate.…”

Section: Tacrolimus Proficiency-testing Panelmentioning

confidence: 99%

Standardization of LC-MS for Therapeutic Drug Monitoring of Tacrolimus

et al. 2013

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“…Differently from other reports that showed an overestimation of immunoassays ranging from 11 to 57% forCsA(9-10; 16-18) and 17-18% for Tacr, (19)(20)(21), no consistent biases were evident in our results. As suggested by other authors (12), the absence of biases can suggest a calibration issue or issues with the extraction of CsA or Tacr from whole blood, since all immunoassay-based methods are supposed to cross-react with metabolites and would therefore be expected to report higher concentrations for patient samples compared to LC-MS/MS methods. Other analytical interferences in the ACMIA were associated to the presence of heterofilic or anti-bgalactosidase antibodies in the samples (21)(22)(23).…”

Section: Discussionmentioning

confidence: 97%

Comparison of Antibody-Conjugated Magnetic Immunoassay and Liquid Chromatography-Tandem Mass Spectrometry for the Measurement of Cyclosporine and Tacrolimus in Whole Blood

Cangemi

Bonifazio

Maffia

et al. 2013

Int J Immunopathol Pharmacol

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The aim of this work is to compare the results of a commercially available liquid chromatography tandem mass spectrometry (LC-MS/MS) method in a clinical pathology laboratory for routine Therapeutic Drug Monitoring (TOM) of cyclosporine (CsA) and tacrolimus (Tacr) in pediatric patients with those obtained with the current antibody-conjugated magnetic immunoassay (ACMIA). Whole blood levels of CsA (n= 135) and Tacr (n=100) were sequentially analyzed by using ACMIA and LC-MS/MS on pediatric transplanted patients. The differences were analyzed by using the Passing Bablok regression analysis and the Bland and Altman test. The LC-MS/MS method showed excellent reproducibility and lower limits of quantification compared to the ACMIA. A linear relationship between ACMIA and LC-MS/MS was obtained for both CsA (r= 0.9449; P

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“…LC-MS/MS methods suffer from higher inter-laboratory CVs due to lack of assay standardization, when compared to immunoassays [51]. Commercial kits are helpful to reduce these variations if several labs use the same kit.…”

Section: Commercialization and Standardization Of Lc-ms/ms Methodsmentioning

confidence: 99%