Evaluation of the Novel Methotrexate Architect Chemiluminescent Immunoassay: Clinical Impact on Pharmacokinetic Monitoring
Autor: | María Concepción Donoso-Rengifo, Julia López-Santamaría, Pablo Montejano Hervás, Inmaculada Reyes-Torres, Maria D. Aumente |
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Rok vydání: | 2017 |
Předmět: |
Adult
Adolescent Pharmacology 030226 pharmacology & pharmacy 03 medical and health sciences Young Adult 0302 clinical medicine Pharmacokinetics Chemiluminescent immunoassay Fluorescence Polarization Immunoassay medicine Humans Pharmacology (medical) Statistical analysis Child Aged Chromatography medicine.diagnostic_test business.industry Significant difference Middle Aged Confidence interval Concordance correlation coefficient Methotrexate 030220 oncology & carcinogenesis Immunoassay Child Preschool Drug Monitoring business medicine.drug |
Zdroj: | Therapeutic drug monitoring. 39(5) |
ISSN: | 1536-3694 |
Popis: | BACKGROUND Fluorescence polarization immunoassay (FPIA) has probably been the most widely used technique for the determination of methotrexate (MTX) concentrations in clinical laboratories. After its replacement by a novel architect chemiluminescent microparticle immunoassay (CMIA), it is essential to verify that there are no differences between the methods that can induce an error in leucovorin rescue with dire consequences for the patient. The objective of our study was to compare plasma/serum MTX measurements between CMIA and FPIA (reference method in this study) in the work conditions of a clinical pharmacokinetics unit to determine whether any difference would affect clinical decisions on the management of this drug. METHODS FPIA on TDx/FLx and CMIA on Architect ci8200 were simultaneously used to evaluate 127 clinical samples. Within-run (20 repetitions on same day) and between-run (20 repetitions on different days) imprecision was evaluated using 6 control samples provided by the manufacturer and diluting 2 of them by 50% for 0.03 and 0.22 μmol/L, respectively. The Passing-Bablok regression method, Bland-Altman plot, and concordance correlation coefficient (CCC) were used in the statistical analysis. RESULTS Within-run imprecision was |
Databáze: | OpenAIRE |
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