Performance evaluation of Siemens ADVIA Centaur® enhanced estradiol assay and a split sample comparison with liquid chromatography-tandem mass spectrometry

Objectives: The objective of this study was to evaluate the newly-developed Siemens ADVIA Centaur (R) enhanced Estradiol (eE2) assay and compare it with a well-established estradiol liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Design and methods: The Siemens eE2 assay was evaluated using the Clinical and Laboratory Standards Institute evaluation protocols. Split patient samples were compared with the eE2 assay, the current ADVIA Centaur E2-6 III assay; and LC-MS/MS method by API5000 mass spectrometer. Results: Within-run and total imprecision of the eE2 assay demonstrated coefficient of variations of 5.7%, 3.2%, 1.5%, and 10.4%, 7.3%, and 6.8%, at levels of 380, 752, and 2051 pmol/L, respectively. The method comparisons showed: eE2=0.903(E2-6 III) -16.2, R-2=0.938, average bias= -12.3%; and eE2=0.946(LC-MS/MS) + 19.5, R-2=0.925, average bias: 0%. Conclusion: The Siemens eE2 assay correlates well with LC-MS/MS. This method is reliable, and appropriate for routine clinical laboratory use. (C) 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.