Should functional sensitivity of a new thyroid stimulating hormone immunoassay be monitored routinely? The ADVIA Centaur TSH3-UL assay experience

Clinical Biochemistry
Nathalie ReixArnaud Agin

Abstract

We emphasize the importance of routine follow-up of subnormal TSH concentrations with QC materials. The functional sensitivity (FS) of the ADVIA Centaur system TSH assay was assessed. We report the values yielded for QC materials in two clinical laboratories. The FS was <0.02 mIU/L. The low-TSH QC (a serum pool) showed unacceptable between-lot imprecision (mean 0.0252 mIU/L, CV 22%). We do encourage healthcare laboratories to constitute low-TSH serum pools to ensure that the results they report meet 3rd-generation criteria.

References

Sep 1, 1990·The Journal of Clinical Endocrinology and Metabolism·J T Nicoloff, C A Spencer
Jan 15, 2004·JAMA : the Journal of the American Medical Association·Martin I SurksNeil J Weissman
Oct 9, 2004·Clinical Chemistry·Mindy L Rawlins, William L Roberts
Apr 17, 2010·Clinical Chemistry·Linda M ThienpontUNKNOWN IFCC Working Group on Standardization of Thyroid Function Tests
Aug 20, 2011·Clinica Chimica Acta; International Journal of Clinical Chemistry·William E OwenWilliam L Roberts

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Citations

Oct 16, 2013·Scandinavian Journal of Clinical and Laboratory Investigation·Margaretha C MinnaardNiek J De Wit
Aug 26, 2017·Journal of Epidemiology and Community Health·Amanda M BarberioLindsay McLaren
Dec 17, 2019·Scandinavian Journal of Clinical and Laboratory Investigation·Bosa Mirjanic-AzaricZana Radic

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