Evaluation of 2 batched pretreatment systems for the measurement of whole blood tacrolimus on the ARCHITECT immunoassay analyzer

Sami Albeiroti, Michael O. Alberti, Vincent Buggs, Gordon Swartz, Anthony W. Butch, Julia C. Drees, Kathleen A. Kelly

Research output: Contribution to journalArticle

2 Scopus citations

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 (R2 values ≥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. Conclusion: The 2 developed batched extraction methods for tacrolimus measurement that we describe herein demonstrate excellent performance and can replace individual specimen extraction.

Original languageEnglish
Pages (from-to)268-274
Number of pages7
JournalLab Medicine
Volume47
Issue number4
DOIs
StatePublished - Nov 1 2016
Externally publishedYes

Keywords

  • ARCHITECT
  • Immunosuppressant
  • Laboratory ergonomics
  • Sirolimus
  • Tacrolimus
  • Therapeutic drug monitoring

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