Clinical Chemistry
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Clinical Chemistry 41: 24-31, 1995;
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Clinical Chemistry, Vol 41, 24-31, Copyright © 1995 by American Association for Clinical Chemistry

Multicenter evaluation of enhanced chemiluminescence labeled-antibody immunoassay (Amerlite-MAB) for free thyroxine

ND Christofides and CP Sheehan
Cardiff Laboratories, Kodak Clinical Diagnostics, Ltd., Amersham, UK.

The technical and diagnostic performance of the Amerlite-MAB enhanced luminescence assay for free thyroxine (FT4) was assessed in a multicenter evaluation trial. The euthyroid central 95% reference range for FT4 (1393 subjects) was 11.5-27.7 pmol/L (by cumulative frequency plot with two-tailed 2.5% cutoffs). Results (y) agreed with those of similar radioactive method (Amerlex-MAB FT4) (x): y = 1.06 x + 0.54, Sylx = 335.5, n = 235). Mean within-assay precision (CV) in six centers was 5.7% at 6 pmol/L and 2.6% at 51 pmol/L FT4; between-assay precision (CV) was 7.2% and 3.6%, respectively. Diagnostic performance was assessed in all patient groups usually encountered, including those with nonthyroidal illness and extreme binding-protein anomalies. In elderly euthyroid subjects, the proportion of above-normal FT4 values exceeded that in younger age-groups. These increases often accompanied normal estimates of thyrotropin and, in some cases, might have arisen by interference from medication that is taken more often by the elderly.




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Copyright © 1995 by the American Association for Clinical Chemistry.