6533b82bfe1ef96bd128d7ad
RESEARCH PRODUCT
Multi-site analytical evaluation of a chemiluminescent magnetic microparticle immunoassay (CMIA) for sirolimus on the Abbott ARCHITECT analyzer.
D. DicksonDaniel KenneyRosemarie SchweigertRainer W. SchmidKarl J. LacknerGiuseppe AimoJohannes LotzThomas RosiereG.t. MaineJudith Friesesubject
Spectrum analyzerClinical BiochemistryHematocritSensitivity and Specificitylaw.inventionMagneticslawAntibody SpecificityTandem Mass SpectrometrymedicineHumansParticle SizeChemiluminescenceDetection limitImmunoassaySirolimusChromatographymedicine.diagnostic_testChemistryMulti siteGeneral MedicineImmunoassay methodImmunoassayLuminescent MeasurementsPositive biasImmunosuppressive AgentsChromatography Liquiddescription
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 ≥ 0.91 at three sites and mean biases of 14%, 25% and 39%. CMIA patient specimen correlations to the Abbott IMx gave R ≥ 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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2009-10-01 | Clinical biochemistry |