Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay

Lauren R Cirrincione; Bridgit O Crews; Jane A Dickerson; Matthew D Krasowski; Jessica Rongitsch; Katherine L Imborek; Zil Goldstein; Dina N Greene

doi:10.1530/EC-21-0550

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Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay

Journal article

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Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay

Lauren R Cirrincione, Bridgit O Crews, Jane A Dickerson, Matthew D Krasowski, Jessica Rongitsch, Katherine L Imborek, Zil Goldstein and Dina N Greene

Endocrine Connections, Vol.11(2), pp.1-8

02/09/2022

DOI: 10.1530/EC-21-0550

PMCID: PMC8859944

PMID: 35015702

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Abstract

Objectives Recently, an estradiol immunoassay manufacturer (Beckman Coulter, USA) issued an ‘important product notice’ alerting clinical laboratories that their assay (Access Sensitive Estradiol) was not indicated for patients undergoing exogenous estradiol treatment. The objective of this analysis was to evaluate immunoassay bias relative to liquid chromatography tandem mass spectrometry (LC-MS/MS) in transgender women and to examine the influence of unconjugated estrone on measurements. Design Cross-sectional secondary analysis. Methods Estradiol concentrations from 89 transgender women were determined by 3 immunoassays (Access Sensitive Estradiol (‘New BC’) and Access Estradiol assays (‘Old BC’), Beckman Coulter; Estradiol III assay (‘Roche’), Roche Diagnostics) and LC-MS/MS. Bias was evaluated with and without adjustment for estrone concentrations. The number of participants who shifted between three estradiol concentration ranges for each immunoassay vs LC-MS/MS (>300 pg/mL, 70–300 pg/mL, and <70 pg/mL) was calculated. Results The New BC assay had the largest magnitude overall bias (median: −34%) and was −40%, −22%, and −10%, among participants receiving tablet, patch, or injection preparations, respectively. Overall bias was −12% and +17% for the Roche and Old BC assays, respectively. When measured with the New BC assay, 18 participants shifted to a lower estradiol concentration range (vs 9 and 10 participants based on Roche or Old BC assays, respectively). Adjustment for estrone did not minimize bias. Conclusions Immunoassay measurement of estradiol in transgender women may lead to falsely decreased concentrations that have the potential to affect management. A multidisciplinary health care approach is needed to ensure if appropriate analytical methods are available.

estrone

estrogens

mass spectrometry

hormone therapy

transgender

estradiol

immunoassay

Details

Title: Subtitle: Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
Creators: Lauren R Cirrincione - University of Washington
Bridgit O Crews - University of California, Irvine
Jane A Dickerson - Seattle Children's Hospital
Matthew D Krasowski - University of Iowa
Jessica Rongitsch - Kaiser Permanente Capitol Hill Medical Center
Katherine L Imborek - University of Iowa
Zil Goldstein - The Graduate Center, CUNY
Dina N Greene - Kaiser Permanente
Resource Type: Journal article
Publication Details: Endocrine Connections, Vol.11(2), pp.1-8
DOI: 10.1530/EC-21-0550
PMID: 35015702
PMCID: PMC8859944
NLM abbreviation: Endocr Connect
ISSN: 2049-3614
eISSN: 2049-3614
Publisher: Bioscientifica Ltd
Alternative title: Falsely low estradiol in a common immunoassay
Language: English
Date published: 02/09/2022
Academic Unit: Pathology; Family and Community Medicine
Record Identifier: 9984297454702771

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