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Validation of the picoAMH assay on the Dynex DS2 platform

OBJECTIVES: Anti-Müllerian hormone (AMH) is increasingly used as a biomarker of ovarian reserve in clinical practice, and is used both for management of fertility treatments and prediction of menopause. We sought to validate the newly FDA-approved Ansh Laboratories MenoCheck picoAMH ELISA on the Dyn...

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Autores principales: Garnett, Emily R, Jariwala, Purviben, Rector, Kesha, Gibbons, William E, Zarutskie, Paul W, Devaraj, Sridevi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804432/
https://www.ncbi.nlm.nih.gov/pubmed/31646166
http://dx.doi.org/10.1016/j.plabm.2019.e00140
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author Garnett, Emily R
Jariwala, Purviben
Rector, Kesha
Gibbons, William E
Zarutskie, Paul W
Devaraj, Sridevi
author_facet Garnett, Emily R
Jariwala, Purviben
Rector, Kesha
Gibbons, William E
Zarutskie, Paul W
Devaraj, Sridevi
author_sort Garnett, Emily R
collection PubMed
description OBJECTIVES: Anti-Müllerian hormone (AMH) is increasingly used as a biomarker of ovarian reserve in clinical practice, and is used both for management of fertility treatments and prediction of menopause. We sought to validate the newly FDA-approved Ansh Laboratories MenoCheck picoAMH ELISA on the Dynex-DS2 platform for clinical use in our obstetrics and gynecology center. DESIGN: Validation of the picoAMH ELISA on the Dynex-DS2 was performed according to CLSI guidelines. Intra- and inter-assay CV, assay linearity, and method comparison studies were carried out to verify assay precision and accuracy. The manufacturer’s reference range was verified using 26 volunteer samples, and interference for hemolysis, lipemia, icterus, and biotin was evaluated. picoAMH results were additionally correlated with antral follicle count by ultrasound. RESULTS: Intra- and inter-assay CV of the picoAMH assay on the DS2 was ≤4% and the assay was linear between concentrations of 0.0067–16.24 ng/mL (0.048–116.0 pmol/L) AMH. Method comparison was performed with the manufacturer’s laboratory and indicated good correlation, with Deming regression yielding slope of 0.928 and intercept of −0.0421. The assay displayed no significant interference from hemolysis (1000 mg/dL), lipemia (2000 mg/dL), conjugated bilirubin (66 mg/dL), or biotin (10,000 ng/mL). Measurement of AMH on the DS2 was also correlated with antral follicle count, with R = 0.7128. CONCLUSIONS: Our results indicate that the picoAMH ELISA on the DS2 has good analytical performance suitable for clinical use.
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spelling pubmed-68044322019-10-23 Validation of the picoAMH assay on the Dynex DS2 platform Garnett, Emily R Jariwala, Purviben Rector, Kesha Gibbons, William E Zarutskie, Paul W Devaraj, Sridevi Pract Lab Med Article OBJECTIVES: Anti-Müllerian hormone (AMH) is increasingly used as a biomarker of ovarian reserve in clinical practice, and is used both for management of fertility treatments and prediction of menopause. We sought to validate the newly FDA-approved Ansh Laboratories MenoCheck picoAMH ELISA on the Dynex-DS2 platform for clinical use in our obstetrics and gynecology center. DESIGN: Validation of the picoAMH ELISA on the Dynex-DS2 was performed according to CLSI guidelines. Intra- and inter-assay CV, assay linearity, and method comparison studies were carried out to verify assay precision and accuracy. The manufacturer’s reference range was verified using 26 volunteer samples, and interference for hemolysis, lipemia, icterus, and biotin was evaluated. picoAMH results were additionally correlated with antral follicle count by ultrasound. RESULTS: Intra- and inter-assay CV of the picoAMH assay on the DS2 was ≤4% and the assay was linear between concentrations of 0.0067–16.24 ng/mL (0.048–116.0 pmol/L) AMH. Method comparison was performed with the manufacturer’s laboratory and indicated good correlation, with Deming regression yielding slope of 0.928 and intercept of −0.0421. The assay displayed no significant interference from hemolysis (1000 mg/dL), lipemia (2000 mg/dL), conjugated bilirubin (66 mg/dL), or biotin (10,000 ng/mL). Measurement of AMH on the DS2 was also correlated with antral follicle count, with R = 0.7128. CONCLUSIONS: Our results indicate that the picoAMH ELISA on the DS2 has good analytical performance suitable for clinical use. Elsevier 2019-09-27 /pmc/articles/PMC6804432/ /pubmed/31646166 http://dx.doi.org/10.1016/j.plabm.2019.e00140 Text en © 2019 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Garnett, Emily R
Jariwala, Purviben
Rector, Kesha
Gibbons, William E
Zarutskie, Paul W
Devaraj, Sridevi
Validation of the picoAMH assay on the Dynex DS2 platform
title Validation of the picoAMH assay on the Dynex DS2 platform
title_full Validation of the picoAMH assay on the Dynex DS2 platform
title_fullStr Validation of the picoAMH assay on the Dynex DS2 platform
title_full_unstemmed Validation of the picoAMH assay on the Dynex DS2 platform
title_short Validation of the picoAMH assay on the Dynex DS2 platform
title_sort validation of the picoamh assay on the dynex ds2 platform
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804432/
https://www.ncbi.nlm.nih.gov/pubmed/31646166
http://dx.doi.org/10.1016/j.plabm.2019.e00140
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