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Multiplex serum biomarker assessments: technical and biostatistical issues.

Butterfield, LH and Potter, DM and Kirkwood, JM (2011) Multiplex serum biomarker assessments: technical and biostatistical issues. Journal of translational medicine, 9. 173 - ?.

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Identification of predictive and prognostic biomarkers for patients with disease and undergoing different therapeutic options is a very active area of investigation. Many of these studies seek biomarkers among circulating proteins accessed in blood. Many levels of standardization in materials and procedures have been identified which can impact the resulting data. Here, we have observed unexpected variability in levels of commonly tested analytes in serum which were processed and stored under standardized conditions. We have identified apparent changes in cytokine, chemokine and growth factor levels detected by multiplex Luminex assay in melanoma patient and healthy donor serum samples, over storage time at -80°C. Controls included Luminex kit standards, multiplexed cytokine standards and WHO cytokine controls. Data were analyzed by Wilcoxon rank-sum testing and Spearman's test for correlations. The interpretation of these changes is confounded by lot-to-lot kit standard curve reagent changes made by a single manufacturer of Luminex kits. This study identifies previously unknown sources of variation in a commonly used biomarker assay, and suggests additional levels of controls needed for identification of true changes in circulating protein levels.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Butterfield, LHlhb3@pitt.eduLHB3
Potter, DM
Kirkwood, JMkirkwood@pitt.eduKIRKWOOD
Centers: Other Centers, Institutes, Offices, or Units > Pittsburgh Cancer Institute
Date: 1 January 2011
Date Type: Publication
Journal or Publication Title: Journal of translational medicine
Volume: 9
Page Range: 173 - ?
DOI or Unique Handle: 10.1186/1479-5876-9-173
Schools and Programs: School of Public Health > Biostatistics
School of Medicine > Immunology
School of Medicine > Medicine
School of Medicine > Surgery
Refereed: Yes
Date Deposited: 26 Oct 2016 17:10
Last Modified: 04 Feb 2019 15:56


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