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Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage

BACKGROUND: Serum follicle stimulating hormone (FSH) levels are used clinically to evaluate infertility, pituitary and gonadal disorders. With increased frequency of research collaborations across institutions, it is essential that inter-laboratory validation is addressed. METHODS: An inter-laborato...

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Autores principales: Scriver, Jessica, Baker, Valerie L, Young, Steven L, Behr, Barry, Pastore, Lisa M
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3009700/
https://www.ncbi.nlm.nih.gov/pubmed/21114859
http://dx.doi.org/10.1186/1477-7827-8-145
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author Scriver, Jessica
Baker, Valerie L
Young, Steven L
Behr, Barry
Pastore, Lisa M
author_facet Scriver, Jessica
Baker, Valerie L
Young, Steven L
Behr, Barry
Pastore, Lisa M
author_sort Scriver, Jessica
collection PubMed
description BACKGROUND: Serum follicle stimulating hormone (FSH) levels are used clinically to evaluate infertility, pituitary and gonadal disorders. With increased frequency of research collaborations across institutions, it is essential that inter-laboratory validation is addressed. METHODS: An inter-laboratory validation of three commercial FSH immunoassays was performed with human serum samples of varying frozen storage length (2 batches of 15 samples each) at -25 degree C. Percentage differences and Bland-Altman limits of agreement were calculated. RESULTS: The inter- and intra-laboratory consistency of FSH values with the same assay manufacturer was much higher after shorter-term storage (frozen for less than 11 months, mean percentage degradation less than 4%) than after long-term storage (2-3 years, mean percentage degradation = 23%). Comparing assay results from different manufacturers, there was similar overall long term degradation as seen with the same manufacturer (-25%), however the degradation was greater when the original FSH was greater than 20 mIU/mL relative to less than 10 mIU/mL (p < 0.001 trend test). CONCLUSION: The findings suggest that degradation of serum samples stored between 11 months and 2-3 years at -25 degrees C can lead to unstable FSH measurements. Inter-laboratory variability due to frozen storage time and manufacturer differences in assay results should be accounted for when designing and implementing research or clinical quality control activities involving serum FSH at multiple study sites.
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spelling pubmed-30097002010-12-24 Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage Scriver, Jessica Baker, Valerie L Young, Steven L Behr, Barry Pastore, Lisa M Reprod Biol Endocrinol Research BACKGROUND: Serum follicle stimulating hormone (FSH) levels are used clinically to evaluate infertility, pituitary and gonadal disorders. With increased frequency of research collaborations across institutions, it is essential that inter-laboratory validation is addressed. METHODS: An inter-laboratory validation of three commercial FSH immunoassays was performed with human serum samples of varying frozen storage length (2 batches of 15 samples each) at -25 degree C. Percentage differences and Bland-Altman limits of agreement were calculated. RESULTS: The inter- and intra-laboratory consistency of FSH values with the same assay manufacturer was much higher after shorter-term storage (frozen for less than 11 months, mean percentage degradation less than 4%) than after long-term storage (2-3 years, mean percentage degradation = 23%). Comparing assay results from different manufacturers, there was similar overall long term degradation as seen with the same manufacturer (-25%), however the degradation was greater when the original FSH was greater than 20 mIU/mL relative to less than 10 mIU/mL (p < 0.001 trend test). CONCLUSION: The findings suggest that degradation of serum samples stored between 11 months and 2-3 years at -25 degrees C can lead to unstable FSH measurements. Inter-laboratory variability due to frozen storage time and manufacturer differences in assay results should be accounted for when designing and implementing research or clinical quality control activities involving serum FSH at multiple study sites. BioMed Central 2010-11-29 /pmc/articles/PMC3009700/ /pubmed/21114859 http://dx.doi.org/10.1186/1477-7827-8-145 Text en Copyright ©2010 Scriver et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Scriver, Jessica
Baker, Valerie L
Young, Steven L
Behr, Barry
Pastore, Lisa M
Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage
title Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage
title_full Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage
title_fullStr Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage
title_full_unstemmed Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage
title_short Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage
title_sort inter-laboratory validation of the measurement of follicle stimulating hormone (fsh) after various lengths of frozen storage
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3009700/
https://www.ncbi.nlm.nih.gov/pubmed/21114859
http://dx.doi.org/10.1186/1477-7827-8-145
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