Analytical and Clinical Performance of an Automated Immunoassay System (Immulite®) for Estradiol in Serum : Clinical Chemistry and Laboratory Medicine

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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.


IMPACT FACTOR 2014: 2.707
Rank 6 out of 30 in category Medical Laboratory Technology in the 2014 Thomson Reuters Journal Citation Report/Science Edition

SCImago Journal Rank (SJR) 2014: 0.741
Source Normalized Impact per Paper (SNIP) 2014: 1.011
Impact per Publication (IPP) 2014: 2.310

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Analytical and Clinical Performance of an Automated Immunoassay System (Immulite®) for Estradiol in Serum

José Rodríguez-Espinosa / Carles Otal-Entraigas / Neus Gascón-Roche / Josefina Mora-Brugués / Eulalia Urgell-Rull / José-Ramón Bordás-Serrat / Pere Viscasillas-Molins

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 36, Issue 12, Pages 969–974, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.1998.167, July 2005

Publication History

Published Online:
2005-07-19

Abstract

The analytical and clinical performance of a commercial automated immunoassay system (Immulite®) for estradiol (E2) in serum was evaluated. The functional sensitivity for E2 was 0.07 nmol/l, and analytical imprecision (<13 %, <9 % and <7 % at 0.22, 0.51 and 1.51 nmol/l, respectively) for concentrations above this detection limit met published analytical goals. The assay recovery was good and the assay was linear over a wide concentration range. No sample carryover was found, and interferences from common substances present in serum were observed only at very high concentrations. Most of samples from men and postmenopausal women showed E2 concentrations below the detection limit. Longitudinal estradiol profiles from 11 healthy menstruating women showed characteristic menstrual cycle patterns (12 samples per subject obtained during a 30-day period). Longitudinal studies on women during induction of ovulation showed that E2 concentrations are highly correlated with the total number of follicles. Our results demonstrate the reliability of this system for routine use in the clinical laboratory.

Citing Articles

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[1]
Karen Pazol, Jay R. Kaplan, David Abbott, Susan E. Appt, and Mark E. Wilson
Clinica Chimica Acta, 2004, Volume 340, Number 1-2, Page 117
[3]
David T. Yang, MD, William Owen, MT(ASCP), Carol Ramsay, Hui Xie, MS, and William Roberts, MD, PhD
American Journal of Clinical Pathology, 2004, Volume 122, Number 3, Page 332

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