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Clinical Chemistry 48: 583-585, 2002;
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(Clinical Chemistry. 2002;48:583-585.)
© 2002 American Association for Clinical Chemistry, Inc.


Technical Briefs

Limitations of Steroid Determination by Direct Immunoassay

Joëlle Taieb1a, Clarisse Benattar1, Anne Sophie Birr1 and Albert Lindenbaum1

1 Department of Biochemistry and Hormonology, Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart cedex, France

aauthor for correspondence: fax 33-1-45374745, e-mail joelle.taieb@abc.ap-hop-paris.fr

Rapid steroid hormone immunoassays often agree poorly, especially at normal and low concentrations (1)(2)(3)(4). These problems result from low assay specificity, inadequate standardization, and poor optimization of the methods over the large range of concentrations seen clinically (5)(6)(7). These systems are often unsuitable for clinical applications that require a low detection limit, such as the following: (a) estradiol measurements in men [<110 pmol/L; (<30 pg/mL)] or children [from <18 pmol/L to 165 pmol/L (<5 pg/mL to 45 pg/mL)] (8) and evaluation of down-regulation by gonadoliberin analogs before in vitro fertilization and embryo transfer (IVF-ET) programs; (b) progesterone determinations during ovarian stimulation, with values <3.2 nmol/L (<1 ng/mL) on the day of human chorionic gonadotropin administration predictive for pregnancy in IVF-ET (9)(10); (c) testosterone assays for children [from <0.35 nmol/L to 5 nmol/L (<0.1 ng/mL to 1.5 ng/mL)] and women [<2.4 nmol/L (<0.7 ng/mL)] (11)(12). Furthermore, limits of detection determined with the zero calibrator are generally far below the lowest concentration that can be reliably quantified in human serum [functional sensitivity (13)(14) or limit of quantitation (LOQ) (15)].

In this study, we analyzed and compared detection limits and functional sensitivities for nine estradiol (E2) and eight progesterone (P) immunoassays.

Between 1997 and 2001, we tested nine . . . [Full Text of this Article]


Acknowledgments


References




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