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- Title
Evaluation of 2 Batched Pretreatment Systems for the Measurement of Whole Blood Tacrolimus on the ARCHITECT Immunoassay Analyzer.
- Authors
Albeiroti, Sami; Alberti, Michael O.; Buggs, Vincent; Swartz, Gordon; Butch, Anthony W.; Drees, Julia C.; Kelly, Kathleen A.
- 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 individualextraction 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.
- Subjects
IMMUNOASSAY; TACROLIMUS; ERGONOMICS; LABORATORIES; RESEARCH methodology; EQUIPMENT &; supplies
- Publication
Laboratory Medicine, 2016, Vol 47, Issue 4, p268
- ISSN
0007-5027
- Publication type
Article
- DOI
10.1093/labmed/lmw032