Multicenter evaluation of the new immunoassay method for TSH measurement using the automated DxI platform

Ruggero Dittadi, Sara Rizzardi, Silvia Masotti, Concetta Prontera, Andrea Ripoli, Antonio Fortunato, Antonio Alfano, Cinzia Carrozza, Mario Correale, Gianluca Gessoni, Marco Migliardi, Giancarlo Zucchelli, Aldo Clerico

Risultato della ricerca: Contributo in rivistaArticolo in rivista

7 Citazioni (Scopus)


Aim of the study: Recently, Beckman Coulter Diagnostics set up a new TSH immunoassay for the automated DxI platform. The aim of this study was to evaluate and compare the analytical performance and clinical results of this method with those of previous method. Material and methods: A multicenter study (named TSH ELAS Study) was organized using 593 serum samples, collected from healthy subjects and patients with thyroid disorders, and 13 control samples, circulated in an External Quality Assessment (EQA) scheme. Results: The values of LoB and LoD, and LoQat 20% CV were 0.0004 mIU/L, 0.001 mIU/L and 0.0023 mIU/L, respectively. Moreover, TSH concentrations >0.01 mIU/L actually show imprecision values lower than 5% CV. This new TSH assay showed a systematic underestimation (on average of 6.25%) compared to old method, which is mainly due to larger differences between methods for samples with low TSH concentrations, related to the better analytical sensitivity of new compared to old method. In a reference population, including 279 apparently healthy adult subjects, Caucasian volunteers (mean age 43.6 years, age 20-63 years, 138 women and 141 males) the distribution of TSH concentrations was: mean (CI 95%) 1.694 mIU/L (1.588-1.779), median 1.495 mIU/L (1.412-1.588 mIU/L), 97.5th percentile 3.707 mIU/L. Conclusions: The new TSH immunoassay for DxI platform shows some relevant improvements compared to the previous one: use of the most recent WHO 3rd IRP 81/563 standard and monoclonal antibodies (instead of poly clonal antibodies of the old method), and better analytical sensitivities and reproducibility. (C) 2017 Elsevier B.V. All rights reserved.
Lingua originaleEnglish
pagine (da-a)105-110
Numero di pagine6
RivistaClinica Chimica Acta
Stato di pubblicazionePubblicato - 2017


  • Article
  • Automation
  • Beckman coulter
  • Case-Control Studies
  • DxI platform
  • Female
  • Humans
  • Immunoassay
  • Immunoassay methods
  • Male
  • Middle Aged
  • Quality Control
  • Quality control
  • Quality specification
  • Reference Values
  • Reproducibility of Results
  • TSH
  • Thyroid Neoplasms
  • Thyrotropin
  • Young Adult
  • aged
  • analytical parameters
  • automation
  • blood
  • case control study
  • clinical article
  • clinical trial
  • controlled study
  • evaluation study
  • female
  • human
  • immunoassay
  • immunoassay analyzer
  • intermethod comparison
  • limit of blank
  • limit of detection
  • limit of quantitation
  • major clinical study
  • male
  • middle aged
  • monoclonal antibody
  • multicenter study
  • procedures
  • quality control
  • reference value
  • reproducibility
  • sensitivity analysis
  • standards
  • thyroid disease
  • thyroid tumor
  • thyrotropin
  • thyrotropin blood level
  • thyrotropin, adult
  • young adult, Adult


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