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, Italian Section of the European Ligand Assay Society (ELAS)

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Abstract

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 LoQ at 20% CV were 0.0004mIU/L, 0.001mIU/L and 0.0023mIU/L, respectively. Moreover, TSH concentrations >0.01mIU/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 43.6years, age 20-63years, 138 women and 141 males) the distribution of TSH concentrations was: mean (CI 95%) 1.694mIU/L (1.588-1.779), median 1.495mIU/L (1.412-1.588mIU/L), 97.5th percentile 3.707mIU/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 polyclonal antibodies of the old method), and better analytical sensitivities and reproducibility.

Original languageEnglish
Pages (from-to)105-110
Number of pages6
JournalClinica Chimica Acta
Volume468
DOIs
Publication statusPublished - May 2017

Keywords

  • Journal Article

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    Dittadi, R., Rizzardi, S., Masotti, S., Prontera, C., Ripoli, A., Fortunato, A., Alfano, A., Carrozza, C., Correale, M., Gessoni, G., Migliardi, M., Zucchelli, G., Clerico, A., & Italian Section of the European Ligand Assay Society (ELAS) (2017). Multicenter evaluation of the new immunoassay method for TSH measurement using the automated DxI platform. Clinica Chimica Acta, 468, 105-110. https://doi.org/10.1016/j.cca.2017.02.006