Assuntos
Cromatografia Líquida de Alta Pressão/instrumentação , Monitoramento de Medicamentos/instrumentação , Monitoramento de Medicamentos/métodos , Ácido Micofenólico/sangue , Coleta de Amostras Sanguíneas/instrumentação , Cromatografia Líquida de Alta Pressão/métodos , Humanos , Imunossupressores/sangueRESUMO
Cyclosporine A (CsA) is a potent immunosuppressive agent used in solid organ and bone marrow transplantation. Because of the narrow therapeutic range and variable pharmacokinetics, blood levels of CsA are routinely monitored. The performance of the CEDIA CsA PLUS whole blood immunoassay was evaluated on the Olympus AU400 trade mark, and results were compared to those obtained by high-performance liquid chromatography (HPLC), enzyme-multiplied immunoassay technique (EMIT), and fluorescence polarization immunoassay (FPIA). A total of 592 whole blood samples from patients receiving CsA were tested by each of the assays. CEDIA was linear from 25 to 2000 micro g/L. Total imprecision ranged from 2.7% to 8.7% at CsA values between 48 and 1502 micro g/L. Recovery of added CsA was within 10% of assigned values and was unaffected by bilirubin and lipemia. Metabolite cross-reactivity at 500 micro g/L was 8.1% for AM1, 21.7% for AM4n, and 32.5% for AM9. Regression analysis revealed the following: HPLC = 0.93. CEDIA - 21.2 (r = 0.975), EMIT = 1.08. CEDIA - 25.2 (r = 0.982), and FPIA = 1.14. CEDIA + 13.4 (r = 0.984). CEDIA has acceptable analytical performance for routine CsA monitoring. Advantages are the absence of an extraction step and an extended measuring range. The disadvantage is the high metabolite cross-reactivity; however, results were similar to EMIT
Assuntos
Ciclosporina/sangue , Imunoensaio/métodos , Imunossupressores/sangue , Cromatografia Líquida de Alta Pressão , Reações Cruzadas , Técnica de Imunoensaio Enzimático de Multiplicação , Imunoensaio de Fluorescência por Polarização , Humanos , Imunoensaio/instrumentação , Análise de Regressão , Reprodutibilidade dos TestesRESUMO
OBJECTIVES: Evaluate the performance of the new pretreatment (NPT) reagent for use with the EMIT cyclosporine A (CsA) assay. DESIGN AND METHODS: Samples from transplant patients receiving CsA were tested using a COBAS MIRA S. RESULTS: A downward shift in target values for commercial controls was observed using the NPT reagent. There was excellent correlation for patient results when comparing the NPT reagent with methanol pretreatment. CONCLUSION: The NPT reagent is an acceptable substitute for methanol in the EMIT(R) extraction procedure for CsA.
