Reach further, in an Open Access Journal Endocrinology, Diabetes & Metabolism Case Reports

ISSN 1470-3947 (print)
ISSN 1479-6848 (online)

Searchable abstracts of presentations at key conferences in endocrinology

Published by BioScientifica
Endocrine Abstracts (2010) 22 P812 

Analytical performances and reference ranges of new ultrasensitive TSH and free thyroxine assays on the ADVIA Centaur® Immunoassay Systems

Catherine Massart1, Françoise Gasser2 & Arnaud Agin2,3

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Introduction: Highly sensitive TSH assay is required for thyroid exploration and free thyroxine (T4) concentrations should be measured in some cases of thyroid dysfunction.

Objective: To study the analytical performances and reference ranges of new ultrasensitive TSH (TSH3-UL) and new free T4 (FT4) assays performed on the ADVIA Centaur® Immunoassay Systems (Siemens Healthcare Diagnostics).

Patients and methods: We compared the values of TSH and free T4 measured in 251 sera on the ADVIA Centaur® Systems with the previous (TSH-3 and FT4) and the new (TSH3-UL and FT4) assays. Reference intervals were obtained from 270 blood donors (128 women and 142 men, 20–61 years old) from the Western (n=137) or the Eastern (n=133) regions of France. They were euthyroid, without any medical treatment and negative for the research of anti-thyroperoxidase antibodies (DYNOTest anti-TPOn RIA, Brahms or Access® TPOAb, Beckman Coulter). Regression linear test and Bland-Altman method were used for comparison of results.

Results: Intra- and inter-assay variabilities were correct with CVs ≤5% or ≤7.2% for TSH3-UL or FT4, respectively. The functional sensitivity of the TSH3-UL assay performed on 49 series during a 8 months period was 0.012 mIU/l. Dilution tests carried out on five sera for TSH3-UL assay gave straight lines. Good agreement and excellent correlations were found between the previous and the new assays (r=0.98 and 0.92 for the TSH and the free T4 assays, respectively). The reference range for TSH3-UL performed after logarithmic transformation of values was 0.63–3.4 (median: 1.5) mIU/l. For FT4, the reference range was found at 10.3–17.6 (median:14.3) pmol/l.

Conclusion: The new TSH3-UL shows a functional sensitivity in agreement with NACB guidelines. The reference ranges obtained in a large population of healthy subjects can be used for interpretation of TSH and free T4 results in exploration of thyroid.

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