Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay.

Autor: Winston-McPherson GN; University of Washington, Department of Laboratory Medicine, Seattle, WA, United States., Samraj AN; University of Washington, Department of Laboratory Medicine, Seattle, WA, United States., Poster K; University of Washington, Department of Laboratory Medicine, Seattle, WA, United States., Yamaguchi D; University of Washington, Department of Laboratory Medicine, Seattle, WA, United States., Dickerson JA; Seattle Children's Hospital, Department of Laboratories, Seattle, WA, United States., Drees JC; Kaiser Permanente Regional Laboratories, Northern California, United States., Holmes DT; Department of Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Greene DN; University of Washington, Department of Laboratory Medicine, Seattle, WA, United States. Electronic address: dngreene@uw.edu.
Jazyk: angličtina
Zdroj: Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2018 Mar; Vol. 478, pp. 90-100. Date of Electronic Publication: 2017 Dec 21.
DOI: 10.1016/j.cca.2017.12.029
Abstrakt: Introduction: Beckman Coulter recently reformulated their commercial TSH assay with primary calibration to the World Health Organization 3rd TSH international standard. An extensive evaluation of the performance characteristics for this assay was completed.
Methods: Intra-day and inter-day precision was evaluated using 3 concentrations of commercial quality control material. Linearity, reportable range, stability, sensitivity and susceptibility to common inferences were determined using pooled patient specimens. Inter-assay variability was assessed across 5 different platforms (n=47 patient specimens).
Results: Intra-day and inter-day CVs were <10% at all concentrations evaluated. The LOQ, LOD and LOB were 0.0047μIU/ml (10% CV), 0.0012μIU/ml and 0.0005μIU/ml, respectively. Variable bias was observed for the TSH3 assay when evaluated against the previous generation assay and other platforms, but overall TSH3 gave comparable results.
Conclusions: The TSH3 assay for UniCel DxI 800, is precise, highly sensitive and comparable to the previous generation assay. The assay is acceptable for clinical testing.
(Copyright © 2018 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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