title: Analytical performance characteristics of the Abbott Architect i2000 Tacrolimus assay; comparisons with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Abbott IMx methods.
abstract: BACKGROUND
  Tacrolimus, an immunosuppressive drug discovered in 1984, is used to decrease the risk of organ rejection. The 2007 European Consensus Conference on Tacrolimus Optimization recommended the use of methods with a limit of quantitation at < or =1ng/ml for monitoring low dose tacrolimus therapy.
  
  
  METHODS
  The performance characteristics of the Abbott i2000 Tacrolimus assay were evaluated and compared to LC-MS/MS and Abbott IMx methods.
  
  
  RESULTS
  The limit of detection of the Abbott i2000 method was 0.21ng/ml. Total imprecision was 6.9, 5.8 and 4.2% at three target concentrations of tacrolimus (3.2, 8.5 and 15.9ng/ml) respectively. The method was linear up to 30ng/ml. The limit of quantitation (LOQ) was 0.5ng/ml. Correlation of patient specimen results between the Abbott i2000 method and LC-MS/MS yielded a Deming slope of 1.072ng/ml (CI 1.005 to 1.140), r=0.952 and an intercept of -0.491ng/ml (CI -1.387 to 0.405). The mean bias, as determined by Bland-Altman analysis, was 0.36ng/ml. Comparing results generated by the widely used Abbott IMx assay with LC-MS/MS and Architect i2000 methods yielded Deming slopes of 1.062 and 0.973, with intercepts of -0.214ng/ml and -0.01ng/ml respectively. For both comparisons, r=0.97. The corresponding mean bias of results generated by the Abbott IMx assay (Bland-Altman plots) was 0.53ng/ml vs LC-MS/MS and -0.38ng/ml vs the Architect i2000.
  
  
  CONCLUSIONS
  The Architect i2000 method is a sensitive and highly precise method that achieves a LOQ of <1.0 ng/ml and demonstrated overall accuracy of tacrolimus measurements within 0.4ng/ml.
authors.affiliation: University of Arizona Health Sciences Center, Tucson, AZ, United States. bkde@email.arizona.edu
authors.forename: Barun K
authors.initials: BK
authors.lastname: De
authors.forename: E
authors.initials: E
authors.lastname: Jimenez
authors.forename: S
authors.initials: S
authors.lastname: De
authors.forename: J C
authors.initials: JC
authors.lastname: Sawyer
authors.forename: G A
authors.initials: GA
authors.lastname: McMillin
mesh_terms: D000328:Adult; D015982:Bias; D002853:Chromatography, Liquid / Q000592:standards; D016903:Drug Monitoring / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods* / Q000592:standards; D007166:Immunosuppressive Agents / Q000032:analysis; D057230:Limit of Detection; D008297:Male; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity; D016559:Tacrolimus / Q000032:analysis*; D053719:Tandem Mass Spectrometry / Q000592:standards; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D011933:Reagent Kits, Diagnostic; D016559:Tacrolimus