Two sensitive immunometric assays for serum thyroid stimulating hormone evaluated.
This study was conducted to evaluate the analytical performance (functional sensitivity, reproducibility, parallelism, and accuracy) of two recent commercial kits marketed as third generation immunometric assays for measuring serum thyroid stimulating hormone (TSH). One assay is automated; the other is manual. Accuracy by method comparisons was evaluated using 86 patient samples assayed by an established third generation immunometric assay as the comparative method. The new assays met the third generation criterion for functional sensitivity (CV < or = 20 percent at TSH < or = 0.02 mIU/L), were reproducible (CVs < 11 percent), and measured serum TSH in parallel with the calibrator curves. Linear regression analysis of the intermethod comparison data showed highly correlated (R > .095) results; however, the regression slopes were non-unity, indicating patient sample results were not transferable between methods. Clinical laboratories choosing a third generation TSH assay should validate the performance characteristics of the selected method to ensure reliable results for patient care.
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Department of Pathology and Laboratory Medicine, College of Dental Medicine, Medical University of South Carolina, Charleston 29425, USA.
Papadea
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Didyk
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D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000706:statistics & numerical data; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013972:Thyrotropin / Q000097:blood*
D011933:Reagent Kits, Diagnostic; D013972:Thyrotropin