TY - JOUR
T1 - Comparison of the CEDIA® and MEIA® assays for measurement of tacrolimus in organ transplant recipients
AU - Liang, Shu Ling
AU - Breaud, Autumn
AU - Dunn, Willard
AU - Clarke, William
N1 - Funding Information:
This study was supported in part by Microgenics, Inc.
Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2008/10
Y1 - 2008/10
N2 - Objectives: Tacrolimus is widely used in organ transplantation. We evaluated 2 immunoassays, CEDIA® and MEIA®, for the measurement of whole blood tacrolimus concentrations. Methods: For each assay the following were evaluated: total precision, limit of detection (analytical sensitivity), limit of quantitation (functional sensitivity), linearity, and accuracy. Patient correlation studies were performed, comparing each assay with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Results: Total precision for MEIA, corresponding to mean concentrations of 6.8 and 22.5 ng/ml, was 17.4 and 11.9%, respectively. The limit of detection was 0.9 ng/ml, and the limit of quantitation was 4.7 ng/ml. Total precision for CEDIA, corresponding to mean concentrations of 5.3 and 19.9 ng/ml, was 20.6 and 6.3%, respectively. The limit of detection was 0.8 ng/ml, with a limit of quantitation of 4.9 ng/ml. Analysis of proficiency material demonstrated acceptable performance for both assays. In addition, both assays were acceptably linear over their respective reportable ranges. Analysis of patient correlation data using Passing-Bablok analysis and Bland-Altman plots demonstrated a positive average bias for both assays versus LC-MS/MS results. Conclusion: Based on our evaluation, both assays demonstrated acceptable performance for use in clinical monitoring of tacrolimus.
AB - Objectives: Tacrolimus is widely used in organ transplantation. We evaluated 2 immunoassays, CEDIA® and MEIA®, for the measurement of whole blood tacrolimus concentrations. Methods: For each assay the following were evaluated: total precision, limit of detection (analytical sensitivity), limit of quantitation (functional sensitivity), linearity, and accuracy. Patient correlation studies were performed, comparing each assay with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Results: Total precision for MEIA, corresponding to mean concentrations of 6.8 and 22.5 ng/ml, was 17.4 and 11.9%, respectively. The limit of detection was 0.9 ng/ml, and the limit of quantitation was 4.7 ng/ml. Total precision for CEDIA, corresponding to mean concentrations of 5.3 and 19.9 ng/ml, was 20.6 and 6.3%, respectively. The limit of detection was 0.8 ng/ml, with a limit of quantitation of 4.9 ng/ml. Analysis of proficiency material demonstrated acceptable performance for both assays. In addition, both assays were acceptably linear over their respective reportable ranges. Analysis of patient correlation data using Passing-Bablok analysis and Bland-Altman plots demonstrated a positive average bias for both assays versus LC-MS/MS results. Conclusion: Based on our evaluation, both assays demonstrated acceptable performance for use in clinical monitoring of tacrolimus.
KW - Assay evaluation
KW - Method comparison
KW - Organ transplant
KW - Tacrolimus
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U2 - 10.1016/j.cca.2008.06.007
DO - 10.1016/j.cca.2008.06.007
M3 - Article
C2 - 18606158
AN - SCOPUS:50049126893
SN - 0009-8981
VL - 396
SP - 1
EP - 6
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
IS - 1-2
ER -