Multi-site analytical evaluation of a chemiluminescent magnetic microparticle immunoassay (CMIA) for sirolimus on the Abbott ARCHITECT analyzer.

Objective: This study evaluated a new chemiluminescent magnetic microparticle immunoassay (CMIA) for sirolimus on the ARCHITECT analyzer.

Design And Methods: Patient and laboratory proficiency samples were tested at three European sites and one site in the United States.

Results: The CMIA total %CV's were all <8% and the Limit of Quantification (LOQ) was <1.52 ng/mL across the four sites. It cross-reacts to sirolimus metabolites F4 and F5 and showed no hematocrit interference over a range of 25% to 55%. Patient specimen correlations to three LC/MS/MS methods gave R>or=0.91 at three sites and mean biases of 14%, 25% and 39%. CMIA patient specimen correlations to the Abbott IMx gave R>or=0.94 at 2 sites and mean biases of 5.4% and 6.9%.

Conclusions: CMIA is a precise and sensitive immunoassay method without hematocrit interference. It correlates well to both LC/MS/MS and immunoassay results, but shows an expected positive bias to LC/MS/MS.