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

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...

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Autores principales: Cirrincione, Lauren R, Crews, Bridgit O, Dickerson, Jane A, Krasowski, Matthew D, Rongitsch, Jessica, Imborek, Katherine L, Goldstein, Zil, Greene, Dina N
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Bioscientifica Ltd 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859944/
https://www.ncbi.nlm.nih.gov/pubmed/35015702
http://dx.doi.org/10.1530/EC-21-0550
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author Cirrincione, Lauren R
Crews, Bridgit O
Dickerson, Jane A
Krasowski, Matthew D
Rongitsch, Jessica
Imborek, Katherine L
Goldstein, Zil
Greene, Dina N
author_facet Cirrincione, Lauren R
Crews, Bridgit O
Dickerson, Jane A
Krasowski, Matthew D
Rongitsch, Jessica
Imborek, Katherine L
Goldstein, Zil
Greene, Dina N
author_sort Cirrincione, Lauren R
collection PubMed
description 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.
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spelling pubmed-88599442022-02-23 Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay Cirrincione, Lauren R Crews, Bridgit O Dickerson, Jane A Krasowski, Matthew D Rongitsch, Jessica Imborek, Katherine L Goldstein, Zil Greene, Dina N Endocr Connect Research 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. Bioscientifica Ltd 2022-01-11 /pmc/articles/PMC8859944/ /pubmed/35015702 http://dx.doi.org/10.1530/EC-21-0550 Text en © The authors https://creativecommons.org/licenses/by-nc/4.0/ This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. (https://creativecommons.org/licenses/by-nc/4.0/)
spellingShingle Research
Cirrincione, Lauren R
Crews, Bridgit O
Dickerson, Jane A
Krasowski, Matthew D
Rongitsch, Jessica
Imborek, Katherine L
Goldstein, Zil
Greene, Dina N
Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
title Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
title_full Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
title_fullStr Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
title_full_unstemmed Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
title_short Oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
title_sort oral estrogen leads to falsely low concentrations of estradiol in a common immunoassay
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859944/
https://www.ncbi.nlm.nih.gov/pubmed/35015702
http://dx.doi.org/10.1530/EC-21-0550
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