Searchable abstracts of presentations at key conferences in endocrinology
Endocrine Abstracts (2006) 11 P898

ECE2006 Poster Presentations Thyroid (174 abstracts)

Multicenter evaluation of the Abbott ARCHITECT® anti-Tg and anti-TPO assays

R Anarat 1 , C Bena 2 , H Garth 7 , M Klein 4 , A Radicioni 3 , S Schmitt 4 , C Smith 6 , S Szepanski 5 , M Turanchik 6 & J Waterston 6


1Baskent University, Hastanesi, Turkey; 2Lab. Marcel Merieux, Lyon, France; 3Umberto I Univ. “La Sapienza”, Rome, Italy; 4Gem. Praxis Klein/ Schmitt, Kaiserslautern, Germany; 5Abbott GmbH, Wiesbaden, Germany; 6Fisher Diagnostics Inc, Middletown VA, United States; 7Nuclearmedizin, Hanau, Germany.


The purpose of these studies was to conduct a multi-center evaluation of the performance of the new Abbott ARCHITECT Anti-Tg and Anti-TPO assays. Both assays are two-step, chemiluminescent, microparticle-based immunoassay for the quantitative determination of either the IgG class of thyroglobulin autoantibodies (anti-Tg) or the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma. The ARCHITECT Anti-Tg and Anti-TPO assays are designed to have a dynamic range of 0–1000 IU/ml and are standardized against WHO MRC 65/93 (Anti-Tg) and MRC 66/ 387 (Anti-TPO). Evaluation studies for these assays were conducted at four European sites. Analytical sensitivity, at 95% confidence, was determined to be 0.018 IU/ml (Anti-Tg) and 0.08 IU/ml (Anti-TPO) for 4 runs each. Total variability, determined using the 5-day NCCLS protocol EP10-A2 for low and high controls, ranged from 2.52-8.51%CV for Anti-Tg and 1.31-10.00% CV for Anti-TPO. For method comparison, at minimum 200 patient samples were tested on both ARCHITECT Anti-Tg or Anti-TPO assays and several competitor assays; Concordance was determined as follows: to Centaur® 92.8% for Anti-Tg and 96.6% for Anti TPO; to Autodelphia® 91.5% for Anti-Tg and 98.5% for Anti-TPO, DPC Immulite® xx% for Anti-Tg and xx% for Anti-TPO, Liason® xx% for Anti-Tg and xx% for Anti-TPO, AxSYM® xx% for Anti-Tg and xx% for Anti-TPO and Brahms xx% for Anti-Tg and xx% for Anti-TPO. Based on our evaluation we conclude that the ARCHITECT Anti-Tg and Anti-TPO assays are sensitive, precise and accurate assays, that show good concordance to other test methods.

Volume 11

8th European Congress of Endocrinology incorporating the British Endocrine Societies

European Society of Endocrinology 
British Endocrine Societies 

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