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

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. Intra-day and inter-day precision was evaluated using 3...

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Bibliographic Details
Published in:Clinica chimica acta 2018-03, Vol.478, p.90-100
Main Authors: Winston-McPherson, Gabrielle N., Samraj, Annie N., Poster, Kristina, Yamaguchi, Diane, Dickerson, Jane A., Drees, Julia C., Holmes, Daniel T., Greene, Dina N.
Format: Article
Language:English
Subjects:
3rd IS
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Beckman Coulter
DxI
Harmonization
Immunoassay
TSH
Validation
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Summary: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. 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). Intra-day and inter-day CVs were
ISSN:0009-8981
1873-3492
DOI:10.1016/j.cca.2017.12.029