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

Jessica Scriver, Valerie Baker, Steven L. Young, Barry Behr, Lisa M. Pastore

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number145
JournalReproductive Biology and Endocrinology
Volume8
DOIs
StatePublished - Nov 29 2010
Externally publishedYes

Fingerprint

Follicle Stimulating Hormone
Serum
Gonadal Disorders
Pituitary Diseases
Immunoassay
Research
Quality Control
Infertility

ASJC Scopus subject areas

  • Developmental Biology
  • Endocrinology
  • Reproductive Medicine
  • Medicine(all)

Cite this

Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage. / Scriver, Jessica; Baker, Valerie; Young, Steven L.; Behr, Barry; Pastore, Lisa M.

In: Reproductive Biology and Endocrinology, Vol. 8, 145, 29.11.2010.

Research output: Contribution to journalArticle

@article{105a5d58a4bc4d5e8e27fb6dd85b0696,
title = "Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage",
abstract = "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.",
author = "Jessica Scriver and Valerie Baker and Young, {Steven L.} and Barry Behr and Pastore, {Lisa M.}",
year = "2010",
month = "11",
day = "29",
doi = "10.1186/1477-7827-8-145",
language = "English (US)",
volume = "8",
journal = "Reproductive Biology and Endocrinology",
issn = "1477-7827",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Inter-laboratory validation of the measurement of follicle stimulating hormone (FSH) after various lengths of frozen storage

AU - Scriver, Jessica

AU - Baker, Valerie

AU - Young, Steven L.

AU - Behr, Barry

AU - Pastore, Lisa M.

PY - 2010/11/29

Y1 - 2010/11/29

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=78649373538&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=78649373538&partnerID=8YFLogxK

U2 - 10.1186/1477-7827-8-145

DO - 10.1186/1477-7827-8-145

M3 - Article

C2 - 21114859

AN - SCOPUS:78649373538

VL - 8

JO - Reproductive Biology and Endocrinology

JF - Reproductive Biology and Endocrinology

SN - 1477-7827

M1 - 145

ER -