title: Comparison of antibody-conjugated magnetic immunoassay and liquid chromatography-tandem mass spectrometry for the measurement of cyclosporine and tacrolimus in whole blood.
abstract: The aim of this work is to compare the results of a commercially available liquid chromatography tandem mass spectrometry (LC-MS/MS) method in a clinical pathology laboratory for routine Therapeutic Drug Monitoring (TDM) of cyclosporine (CsA) and tacrolimus (Tacr) in pediatric patients with those obtained with the current antibody-conjugated magnetic immunoassay (ACMIA). Whole blood levels of CsA (n= 135) and Tacr (n=100) were sequentially analyzed by using ACMIA and LC-MS/MS on pediatric transplanted patients. The differences were analyzed by using the Passing Bablok regression analysis and the Bland and Altman test. The LC-MS/MS method showed excellent reproducibility and lower limits of quantification compared to the ACMIA. A linear relationship between ACMIA and LC-MS/MS was obtained for both CsA Tacr. No significant inter-method biases were observed. The analytical performances of the LC-MS/MS method make it suitable for the accurate measurement of CsA and Tacr in pediatric transplanted patients. However ACMIA results are also accurate and reliable. For this reason the choice of the method to be used in a routine clinical pathology laboratory can be made on the bases of non-analytical considerations such as costs, organization, availability of skilled personnel.
authors.affiliation: Laboratorio Centrale di Analisi, Istituto Giannina Gaslini, Genoa, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Cangemi
authors.forename: S
authors.initials: S
authors.lastname: Barco
authors.forename: P
authors.initials: P
authors.lastname: Bonifazio
authors.forename: A
authors.initials: A
authors.lastname: Maffia
authors.forename: A
authors.initials: A
authors.lastname: Agazzi
authors.forename: G
authors.initials: G
authors.lastname: Melioli
mesh_terms: D000367:Age Factors; D000906:Antibodies; D016026:Bone Marrow Transplantation; D002853:Chromatography, Liquid; D016572:Cyclosporine / Q000097:blood*; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D007118:Immunoassay; D007166:Immunosuppressive Agents / Q000097:blood*; D016030:Kidney Transplantation; D057230:Limit of Detection; D016014:Linear Models; D008280:Magnetics; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D016559:Tacrolimus / Q000097:blood*; D053719:Tandem Mass Spectrometry
chemical_list: D000906:Antibodies; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus