Thyroid function testing evaluated on three immunoassay systems

Total thyroxine (TT4), tracer uptake, thyroid-stimulating hormone (TSH), and free T4 (FT4) testing was examined in the ACS 180, Abbott IMx, and Stratus II systems. TSH sensitivity studies demonstrated that the ACS and IMx are second-generation assays; the Stratus showed between first- and second-generation performance. Except for one control below the detection limit, TSH imprecision was 3-10%. TSH accuracy was adequate for all systems. TT4 imprecision was 4-7%, except for the lowest control with the Stratus (18%). TT4 method agreement showed bias of about 20% between the systems. TT4 accuracy was compromised at the low end for the Stratus II, but was satisfactory otherwise. FT4 imprecision was 20% for the Stratus, < 5% for the IMx and 6% for the ACS. Uptake assays showed imprecision of 5-10%. The laboratory diagnosis indicated by each system's FT4 and calculated FT4 Index results were compared to determine diagnostic accuracy. In routine specimens, different clinical classifications were observed for 25% of specimens with the ACS, 19% with the Stratus, and 7% with the IMx; in the altered protein group, the Stratus showed 9% discordant results, the ACS showed 3%, and the IMx 0%. Of the three systems examined here, the Abbott IMx system showed the best overall performance.