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Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine

(2014) THERAPEUTIC DRUG MONITORING. 36(5). p.640-650
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Abstract
Background: Cyclosporine A (CsA) is used as a posttransplantation immunosuppressant drug, and careful monitoring of CsA concentration in whole blood is essential. A new automated electrochemiluminescence immunoassay (ECLIA) for CsA measurement has been assessed in a multicenter evaluation. Methods: Residual EDTA whole blood samples from patients undergoing CsA therapy after organ transplant were used in assay evaluation at 5 clinical laboratories in Europe. Experiments included imprecision according to CLSI EP5-A2 (within-run and intermediate), lower limit of quantification, linearity according to CLSI EP6A, and recovery of commercial external quality control samples. In addition, comparisons to liquid chromatography-tandem mass spectrometry methods in routine use at each investigational site and to commercial chemiluminescent microparticle immunoassay and antibody-conjugated magnetic immunoassay methods were performed. Results: Imprecision testing gave coefficients of variation of less than 9% in the 30-2000 mcg/L range for both within-run and intermediate imprecision. Lower limit of quantification of 6.8 mcg/L at one investigational site and 1.8 mcg/L at a second site at 20% coefficient of variation were observed. Linearity was measured over the concentration range 0-2000 mcg/L, yielding a deviation of less than +/- 12%. External quality control sample recovery by ECLIA was 93%-114% of LC-MS/MS sample recovery. Deming regression analysis of ECLIA method comparison to combined LC-MS/MS results yielded a slope of 1.04 [95% confidence interval (CI), 1.03-1.06] and intercept of 2.8 mcg/L (95% CI, 1.5-4.1 mcg/L). Comparison to chemiluminescent microparticle immunoassay yielded a slope of 0.87 (95% CI, 0.85-0.89) and intercept of 1.4 mcg/L (95% CI, -0.89 to 3.7 mcg/L); comparison to antibody-conjugated magnetic immunoassay yielded a slope of 0.96 (95% CI, 0.93-0.98) and intercept of 24.2 mcg/L (95% CI, -7.1 to -1.2 mcg/L). Conclusions: The data from this multicenter evaluation indicate that the new ECLIA-based cyclosporine assay is fit for its purpose, the therapeutic monitoring of CsA.
Keywords
immunoassay, cyclosporine, therapeutic drug monitoring, WHOLE-BLOOD, RENAL-TRANSPLANTATION, TACROLIMUS, EXPERIENCE, DRUGS

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MLA
Vogeser, Michael et al. “Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine.” THERAPEUTIC DRUG MONITORING 36.5 (2014): 640–650. Print.
APA
Vogeser, M., Shipkova, M., Rigo-Bonnin, R., Wallemacq, P., Orth, M., Widmann, M., & Verstraete, A. (2014). Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine. THERAPEUTIC DRUG MONITORING, 36(5), 640–650.
Chicago author-date
Vogeser, Michael, Maria Shipkova, Raül Rigo-Bonnin, Pierre Wallemacq, Matthias Orth, Monika Widmann, and Alain Verstraete. 2014. “Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine.” Therapeutic Drug Monitoring 36 (5): 640–650.
Chicago author-date (all authors)
Vogeser, Michael, Maria Shipkova, Raül Rigo-Bonnin, Pierre Wallemacq, Matthias Orth, Monika Widmann, and Alain Verstraete. 2014. “Multicenter Analytical Evaluation of the Automated Electrochemiluminescence Immunoassay for Cyclosporine.” Therapeutic Drug Monitoring 36 (5): 640–650.
Vancouver
1.
Vogeser M, Shipkova M, Rigo-Bonnin R, Wallemacq P, Orth M, Widmann M, et al. Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine. THERAPEUTIC DRUG MONITORING. 2014;36(5):640–50.
IEEE
[1]
M. Vogeser et al., “Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine,” THERAPEUTIC DRUG MONITORING, vol. 36, no. 5, pp. 640–650, 2014.
@article{5993454,
  abstract     = {Background: Cyclosporine A (CsA) is used as a posttransplantation immunosuppressant drug, and careful monitoring of CsA concentration in whole blood is essential. A new automated electrochemiluminescence immunoassay (ECLIA) for CsA measurement has been assessed in a multicenter evaluation. 
Methods: Residual EDTA whole blood samples from patients undergoing CsA therapy after organ transplant were used in assay evaluation at 5 clinical laboratories in Europe. Experiments included imprecision according to CLSI EP5-A2 (within-run and intermediate), lower limit of quantification, linearity according to CLSI EP6A, and recovery of commercial external quality control samples. In addition, comparisons to liquid chromatography-tandem mass spectrometry methods in routine use at each investigational site and to commercial chemiluminescent microparticle immunoassay and antibody-conjugated magnetic immunoassay methods were performed. 
Results: Imprecision testing gave coefficients of variation of less than 9% in the 30-2000 mcg/L range for both within-run and intermediate imprecision. Lower limit of quantification of 6.8 mcg/L at one investigational site and 1.8 mcg/L at a second site at 20% coefficient of variation were observed. Linearity was measured over the concentration range 0-2000 mcg/L, yielding a deviation of less than +/- 12%. External quality control sample recovery by ECLIA was 93%-114% of LC-MS/MS sample recovery. Deming regression analysis of ECLIA method comparison to combined LC-MS/MS results yielded a slope of 1.04 [95% confidence interval (CI), 1.03-1.06] and intercept of 2.8 mcg/L (95% CI, 1.5-4.1 mcg/L). Comparison to chemiluminescent microparticle immunoassay yielded a slope of 0.87 (95% CI, 0.85-0.89) and intercept of 1.4 mcg/L (95% CI, -0.89 to 3.7 mcg/L); comparison to antibody-conjugated magnetic immunoassay yielded a slope of 0.96 (95% CI, 0.93-0.98) and intercept of 24.2 mcg/L (95% CI, -7.1 to -1.2 mcg/L). 
Conclusions: The data from this multicenter evaluation indicate that the new ECLIA-based cyclosporine assay is fit for its purpose, the therapeutic monitoring of CsA.},
  author       = {Vogeser, Michael and Shipkova, Maria and Rigo-Bonnin, Raül and Wallemacq, Pierre and Orth, Matthias and Widmann, Monika and Verstraete, Alain},
  issn         = {0163-4356},
  journal      = {THERAPEUTIC DRUG MONITORING},
  keywords     = {immunoassay,cyclosporine,therapeutic drug monitoring,WHOLE-BLOOD,RENAL-TRANSPLANTATION,TACROLIMUS,EXPERIENCE,DRUGS},
  language     = {eng},
  number       = {5},
  pages        = {640--650},
  title        = {Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine},
  url          = {http://dx.doi.org/10.1097/FTD.0000000000000068},
  volume       = {36},
  year         = {2014},
}

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