Abstract
Serum estradiol (E2) levels may be used in the diagnostic and/or monitoring of a broad variety of clinical conditions. The aims of this study were to evaluate the Siemens enhanced estradiol assay (eE2) on Atellica IM 1600 (Siemens Healthineers) and to perform a sample comparison with the Siemens ADVIA Centaur XP (Siemens Healthineers). Within-day and between-day coefficient of variation (CV) were determined using serum sample pools and quality control materials. Six serum samples with decreasing concentrations of E2 were used to assess the limit of quantification. Linearity was evaluated using two different serum samples. Accuracy was evaluated by measuring three certified reference materials. Passing-Bablok regression and Bland-Altman plot were used for comparing Atellica and Centaur XP in 119 serum samples ranging from 45 to 10,059pmol/L. Within-day and between-day imprecision was <6.6%. Accuracy was <6.0% for all values except for 114pmol/L (22%). The study of limit of quantification resulted in an interday imprecision <20%. High correlation between measured and expected estradiol dilution results was observed (R=0.99), with recoveries ranging from 77 to 93%. Comparison study showed good agreement and no significant bias. The study shows that Atellica eE2 assay presents acceptable imprecision and accuracy and correlates well with Centaur XP.
Highlights
Estradiol (17β-estradiol) (E2) is the most potent one of naturally occurring estrogens and the most widely analyzed one in clinical routine and research laboratories
We evaluated the analytical performance of the direct immunoassay Atellica IM 1600 enhanced estradiol assay (Siemens Healthineers, Erlangen, Germany)
The intraday imprecision (CV from 1.8% to 4.0%) and interday imprecision (CV from 1.0% to 6.6%) were satisfactory at the five different concentrations of quality controls and serum pools and met the desirable specification for imprecision based on biological variation (
Summary
Estradiol (17β-estradiol) (E2) is the most potent one of naturally occurring estrogens and the most widely analyzed one in clinical routine and research laboratories. Serum E2 presents a wide range of reference intervals and clinical applications that determine a need to maintain analytical quality specifications in a wide analytical range. In this regard, assessment of the analytical capacity of an E2 assay is critical when considering its reliability to answer specific clinical or research questions [2]. The aims of this study were to evaluate the Siemens enhanced estradiol assay (eE2) on Atellica IM 1600 (Siemens Healthineers) and to perform a sample comparison with the Siemens ADVIA Centaur XP (Siemens Healthineers).
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