Korean J Clin Pathol.  2002 Apr;22(2):95-100.

Evaluation of the TSH, Free Triiodothyronine, Free Thyroxine and Estradiol Test of the Vitros ECi(R) Immunodiagnostic System

• Yong DE
• Sun YK
• Yi KS
• Kim JH
• Kwon OH

Abstract

BACKGROUND: The analytical performance of the Vitros ECi(R) Immunodiagnostic System on the thyroid stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4) and estradiol (E2) assays, which are based on electrochemical luminescence to replace the radioimmunoassay was evaluated.
METHODS
The precision as measured by the NCCLS protocol and a comparison of the method were done for each TSH, FT3, FT4, and E2 assay. The functional sensitivity and linearity tests were performed for both TSH and E2. The free hormone validity test was performed for both the FT3 and FT4.
RESULTS
All four analytes showed an acceptable precision. The functional sensitivities of TSH and E2 were 0.007 mIU/L, and 87 pmol/L, respectively. TSH and E2 showed excellent linearity up to 78 mIU/mL, and up to 7,700 pmol/L, respectively. The free hormone validity test showed acceptable results demonstrating accurate free hormone determination. The E2 showed a significant proportion-al bias requiring an adjustment of the reference range, However, the other analytes showed good agreement with a slight proportional bias.
CONCLUSIONS
The TSH, FT3, FT4, and E2 assay by Vitros ECi(R) exhibited excellent performance overcoming the drawbacks of a conventional radioimmunoassay.

Keyword

Chemiluminescence immunoassay; TSH; Free triiodothyronine; Free thyroxine; Estradiol

MeSH Terms

Bias (Epidemiology)
Estradiol*
Luminescence
Radioimmunoassay
Reference Values
Thyrotropin
Thyroxine*
Triiodothyronine*
Estradiol
Thyrotropin
Thyroxine
Triiodothyronine