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 01000 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.
01 - 05 Apr 2006
European Society of Endocrinology