Yu Chen1, Lois Kinney2, Steven J Soldin3. 1. Division of Clinical Biochemistry, Department of Laboratory Medicine, Dr. Everett Chalmers Regional Hospital, Horizon Health Network, Fredericton, New Brunswick, Canada E3B 5 N5. Electronic address: yu.chen@horizonNB.ca. 2. Division of Clinical Biochemistry, Department of Laboratory Medicine, Dr. Everett Chalmers Regional Hospital, Horizon Health Network, Fredericton, New Brunswick, Canada E3B 5 N5. 3. Georgetown-Howard Universities Center for Clinical and Translational Sciences, Georgetown University Medical Center, Washington, District of Columbia, USA 20007.
Abstract
OBJECTIVES: The objective of this study was to evaluate the newly developed Siemens ADVIA Centaur 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 Ill 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.
OBJECTIVES: The objective of this study was to evaluate the newly developed Siemens ADVIA Centaur 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 Ill 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.