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

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...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Clinica chimica acta 2018-03, Vol.478, p.90-100
Hauptverfasser: Winston-McPherson, Gabrielle N., Samraj, Annie N., Poster, Kristina, Yamaguchi, Diane, Dickerson, Jane A., Drees, Julia C., Holmes, Daniel T., Greene, Dina N.
Format: Artikel
Sprache:eng
Schlagworte:
3rd IS
Access
Beckman Coulter
Bias
Calibration
Clinical Laboratory Techniques - instrumentation
Clinical Laboratory Techniques - standards
DxI
Harmonization
Humans
Immunoassay
Quality Control
Reproducibility of Results
Thyrotropin - analysis
TSH
Validation
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung: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