title: Evaluation of a microparticle enzyme immunoassay for the measurement of sirolimus in whole blood (Abbott IMx sirolimus).
abstract: An immunoassay of sirolimus based on the microparticle enzyme immunoassay (MEIA) principle was evaluated on 105 whole blood samples (EDTA) drawn from a population of renal (n = 38) and hepatic or heart (n = 3) transplant patients. Each blood sample was analyzed simultaneously by MEIA and by a liquid chromatography mass spectrometry (LC-MS) method. The statistical analysis according to Passing-Bablok (x= LCMS, y= mean of two measurements of the same samples on IMx) produced the following results: Spearman r value = 0.9651, y(MEIA) = 0.99x (LCMS) - 0.26 microg/l. The analytical performance of the MEIA method showed a CV < or = 10% and a lower limit of quantification of 1.5 microg/l, which are acceptable for routine clinical monitoring. In conclusion, the MEIA method has shown robust, stable and reproducible features with an excellent correlation with the LC-MS method.
authors.affiliation: University Hospital Basel, Clinical Chemistry Laboratory, Basel, CH-4031 Switzerland. ascholer@uhbs.ch
authors.forename: André
authors.initials: A
authors.lastname: Scholer
authors.forename: Richard
authors.initials: R
authors.lastname: Von Rickenbach
authors.forename: Genevieve
authors.initials: G
authors.lastname: Faffa
authors.forename: Beatrice
authors.initials: B
authors.lastname: Vetter
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods*; D002853:Chromatography, Liquid; D005069:Evaluation Studies as Topic; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D013058:Mass Spectrometry; D016377:Organ Transplantation; D020123:Sirolimus / Q000737:chemistry / Q000302:isolation & purification*
chemical_list: D020123:Sirolimus