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Should functional sensitivity of a new thyroid stimulating hormone immunoassay be monitored routinely? The ADVIA
Nathalie Reix1, Catherine Massart, Françoise Gasser
1Laboratoire d'Explorations Fonctionnelles par les Isotopes, Hôpitaux Universitaires de Strasbourg, 1 place de l'Hôpital, 67091 Strasbourg Cedex, France.
Objectives:
We emphasize the importance of routine follow-up of subnormal TSH concentrations with QC materials.
Design And Methods:
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.
Results:
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%).
Conclusion:
We do encourage healthcare laboratories to constitute low-TSH serum pools to ensure that the results they report meet 3rd-generation criteria.
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