One-step, labeled-antibody assay for measuring free thyroxin. II. Performance in a multicenter trial

The technical and diagnostic performance of a labeled antibody radioassay for free thyroxin (Amerlex-MAB* FT4) was examined in a multicenter trial. The overall mean within-assay precision (CV) in eight centers was 6.2% at 30 pmol/L and 3.6% at 13 pmol/L concentrations of FT4. Between-assay precision was 5.4% at 18 pmol/L and 6.8% at 50 pmol/L. The euthyroid central 95% reference range for FT4 was 11.3 to 24.3 pmol/L. Results of the method correlated well with those of an analog radioimmunoassay: [Amerlex-MAB* FT4] = 1.09 [Amerlex-M FT4] + 1.50 pmol/L (r = 0.96, n = 732). Clinical performance of the assay was better than that of first-generation analog tracer assays for sera from patients with nonthyroidal illness or binding-protein abnormalities.