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

Nathalie Reix (1, 2) , Catherine Massart (3) , Françoise Gasser (1, 2) , Béatrice Heurtault (1, 4) , Arnaud Agin (1, 2)

1 Laboratoire d'Explorations Fonctionnelles par les Isotopes
2 Société Française de Médecine Nucléaire
3 Unité Laboratoire CIC
4 CAMB - Conception et application de molécules bioactives

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.

Mots clés: Thyroid-stimulating hormone; Functional sensitivity; Third-generation potential; QC materials

Domaines: Biochimie, Biologie Moléculaire

Nathalie Reix, Catherine Massart, Françoise Gasser, Béatrice Heurtault, Arnaud Agin. Should functional sensitivity of a new thyroid stimulating hormone immunoassay be monitored routinely? The ADVIA Centaur TSH3-UL assay experience.. Clinical Biochemistry, 2012, 45 (15), pp.1260-2. ⟨10.1016/j.clinbiochem.2012.04.017⟩. ⟨hal-00878835⟩