Development of an Abbott ARCHITECT cyclosporine immunoassay without metabolite cross-reactivity

Brate, Elaine M.; Finley, David M.; Grote, Jonathan; Holets-McCormack, Shelley R.; Ozaeta, P.; Pacenti, David P.; Peart, Joan E.; Piktel, Ryan; Ramsay, Carol; Rupprecht, Kevin; Saldana, Sylvia C.; Spring, Thomas G.; Tetin, Sergey Y.; Trudeau, Beth; Wang, Phil; Xie, Helen

doi:10.1016/j.clinbiochem.2010.06.007

Cited by 13 publications

(7 citation statements)

References 27 publications

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“…The samples were manually pretreated according to the manufacturer’s instructions and site-specific standard operating procedures. For CSA, 100 µL of Cyclosporine Solubilizing Reagent (4% saponin) and 400 µL of Cyclosporine Precipitation Reagent (zinc sulfate in methanol and ethylene glycol) was added to 200 µL of sample 19 , 20 . For TAC, 200 µL of sample was mixed with 200 µL of Tacrolimus Precipitation Reagent (zinc sulfate in methanol) 21 , 22 .…”

Section: Methodsmentioning

confidence: 99%

Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

et al. 2017

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Therapeutic drug monitoring of immunosuppressant drugs are Background used to monitor drug efficacy and toxicity and to prevent organ transplant rejection. This study evaluates the analytical performance of semi-automated electrochemiluminescence immunoassays (ECLIA) for cyclosporine (CSA), tacrolimus (TAC) and sirolimus (SRL) on the Roche cobas e 411 analyzer at a major transplant hospital to assess method suitability and limitations.: Residual whole blood samples from patients undergoing Methods immunosuppressant therapy were used for evaluation. Imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot comparisons were assessed.: Total imprecision ranged from 3.3 to 7.1% for CSA, 3.9 to 9.4% for Results TAC, and 4.6 to 8.2% for SRL. Linearity was verified from 30.0 to 960.9 μg/L for CSA, from 1.1 to 27.1 μg/L for TAC, and from 0.5 to 32.3 µg/L for SRL. The functional sensitivity met the manufacturer's claims and was determined to be <6.5 μg/L for CSA, 1.1 μg/L for TAC, and <0.1 µg/L for SRL (CV≤20%). : The cobas e 411 ECLIA for CSA, TAC, and SRL have Conclusions acceptable precision, linearity, and functional sensitivity. The method comparisons correlated well with the ARCHITECT immunoassay and LC-MS/MS and is fit for therapeutic drug monitoring

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Section: Methodsmentioning

confidence: 99%

Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

et al. 2017

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“…One is the attempt to reduce cross-reactivity with the immunosuppressant's metabolites. One study of cyclosporine A quantitation found that cross-reactivity with 2 major metabolites (AM1 and AM9) was reduced to less than 1% by using a 2-step chemiluminescent microparticle immunoassay (CMIA) [23]. A sandwich enzyme-linked immunosorbent assay (ELISA), with 2 newly-developed tacrolimus antibodies, demonstrated a reduction in cross-reactivity with 9 out of 11 of tacrolimus' common metabolites and analogs, when compared to an affinity column mediated immunoassay (ACMIA) [24].…”

Section: Immunoassaysmentioning

confidence: 99%

Therapeutic drug monitoring of immunosuppressants by liquid chromatography–mass spectrometry

McShane

Bunch

Wang

2016

Clinica Chimica Acta

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“…These methods included chemiluminescent immunoassay (CMIA), ELISA, enzyme multiplied immunoassay and fluorescence polarization immunoassay. However, these methods lack specificity, as they cannot clearly distinguish CsA from its metabolites (5)(6)(7); this is a significant problem, particularly because the concentration of CsA metabolites increases over the course of treatment.…”

Section: Introductionmentioning

confidence: 99%

Validation of a novel UPLC‑HRMS method for human whole‑blood cyclosporine and comparison with a CMIA immunoassay

et al. 2021

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Development of an Abbott ARCHITECT cyclosporine immunoassay without metabolite cross-reactivity

Cited by 13 publications

References 27 publications

Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer

Therapeutic drug monitoring of immunosuppressants by liquid chromatography–mass spectrometry

Validation of a novel UPLC‑HRMS method for human whole‑blood cyclosporine and comparison with a CMIA immunoassay

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