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

Abstract:

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.

journal_name

Clin Biochem

journal_title

Clinical biochemistry

authors

Reix N,Massart C,Gasser F,Heurtault B,Agin A

doi

10.1016/j.clinbiochem.2012.04.017

subject

Has Abstract

pub_date

2012-10-01 00:00:00

pages

1260-2

issue

15

eissn

0009-9120

issn

1873-2933

pii

S0009-9120(12)00202-0

journal_volume

45

pub_type

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