title: Evaluation of 2 Batched Pretreatment Systems for the Measurement of Whole Blood Tacrolimus on the ARCHITECT Immunoassay Analyzer.
abstract: BACKGROUND
  Measurement of tacrolimus using the ARCHITECT immunoassay analyzer requires a manual extraction step that puts clinical laboratory workers at risk for ergonomic injury. Therefore, we developed 2 batched extraction systems for tacrolimus measurement on the ARCHITECT analyzer and describe their features herein.
  
  
  METHODS
  Two batched extraction methods were developed at 2 different laboratories. The batched extraction methods allow processing of at least 20 specimens at a time. We evaluated the analytical performance of those methods and compared them with the United States Food and Drug Administration (FDA)-cleared process for manually extracting individual specimens.
  
  
  RESULTS
  Comparing the performance of batched- and individual-extraction methods revealed that both methods had comparable between-day imprecision, high patient-results correlation (R2values ≥0.9869), equivalent functional sensitivity (0.48 ng/mL), and good linearity between 1 ng per mL and 25 ng per mL. Further, we observed decreased delta check-identified errors using the batched method.
  
  
  CONCLUSIONS
  The 2 developed batched extraction methods for tacrolimus measurement that we describe herein demonstrate excellent performance and can replace individual specimen extraction.
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Los Angeles (UCLA).
authors.forename: Sami
authors.initials: S
authors.lastname: Albeiroti
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Los Angeles (UCLA).
authors.forename: Michael O
authors.initials: MO
authors.lastname: Alberti
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Los Angeles (UCLA).
authors.forename: Vincent
authors.initials: V
authors.lastname: Buggs
authors.affiliation: Facilities Management, University of California, Los Angeles, CA.
authors.forename: Gordon
authors.initials: G
authors.lastname: Swartz
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Los Angeles (UCLA).
authors.forename: Anthony W
authors.initials: AW
authors.lastname: Butch
authors.affiliation: Kaiser Permanente Northern California Regional Laboratory, Richmond, CA.
authors.forename: Julia C
authors.initials: JC
authors.lastname: Drees
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Los Angeles (UCLA) kkelly@mednet.ucla.edu.
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Kelly
mesh_terms: D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007166:Immunosuppressive Agents / Q000097:blood*; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D016559:Tacrolimus / Q000097:blood*; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: ARCHITECT; immunosuppressant; laboratory ergonomics; sirolimus; tacrolimus; therapeutic drug monitoring