期刊
CYTOKINE
卷 56, 期 2, 页码 430-434出版社
ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.cyto.2011.06.011
关键词
Cytokine measurement; Reproducibility; Multiplex methods; Cervicovaginal secretions; Microbicide studies
资金
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID) [AI065309]
- National Cancer Institute [R37 CA051323]
- STI Clinical Trials Group (NIAID Division of Microbiology and Infectious Diseases) [HHSN266200400074C]
- NIH/NCRR National Center for Research Resources (NCRR) [UL1 RR024131]
The interlaboratory reproducibility of cytokine measurements from cervicovaginal samples by Luminex has not been reported. Using cervicovaginal lavage specimens collected on three study days from 12 women participating in a Phase I microbicide study, we measured a panel of eight cytokines in three independent laboratories. Four (IFN-gamma, IL-10, IL-17, and TNF) were below the limit of detection in the majority (85%) of samples in either two or all three laboratories, an observation that may guide analyte selection for future studies. Good interlaboratory agreement (intraclass correlation coefficient, r > 0.7) in absolute levels was observed for IL-6, and IL-8, while poor agreement was seen for IFN-alpha 2 (r = 0.47). When considering within-subject change from baseline (pre-product, at study-day 0) to either post-product visit (study-days 7 and 14), IL-1 beta and IL-6 exhibited good interlaboratory agreement (r > 0.7), while IFN-alpha 2 and IL-8 did not. Future studies addressing the clinical utility of specific biomarkers of inflammation for microbicide trials should consider reproducibility in the context of defining biologically meaningful thresholds of change for candidate biomarkers, ensuring that such change can be reliably distinguished from background variability. (C) 2011 Elsevier Ltd. All rights reserved.
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