Abstract
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-γ, 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-1β, IL-6, and IL-8, while poor agreement was seen for IFN-α2 (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-1β and IL-6 exhibited good interlaboratory agreement (r>0.7), while IFN-α2 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 430-434 |
| Number of pages | 5 |
| Journal | Cytokine |
| Volume | 56 |
| Issue number | 2 |
| DOIs | |
| State | Published - Nov 2011 |
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Keywords
- Cervicovaginal secretions
- Cytokine measurement
- Microbicide studies
- Multiplex methods
- Reproducibility
ASJC Scopus subject areas
- Immunology
- Immunology and Allergy
- Hematology
- Biochemistry
- Molecular Biology
Cite this
Interlaboratory reproducibility of female genital tract cytokine measurements by Luminex : Implications for microbicide safety studies. / Scott, Mark E.; Wilson, Sarah S.; Cosentino, Lisa A.; Richardson, Barbra A.; Moscicki, Anna Barbara; Hillier, Sharon L.; Herold, Betsy.
In: Cytokine, Vol. 56, No. 2, 11.2011, p. 430-434.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Interlaboratory reproducibility of female genital tract cytokine measurements by Luminex
T2 - Implications for microbicide safety studies
AU - Scott, Mark E.
AU - Wilson, Sarah S.
AU - Cosentino, Lisa A.
AU - Richardson, Barbra A.
AU - Moscicki, Anna Barbara
AU - Hillier, Sharon L.
AU - Herold, Betsy
PY - 2011/11
Y1 - 2011/11
N2 - 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-γ, 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-1β, IL-6, and IL-8, while poor agreement was seen for IFN-α2 (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-1β and IL-6 exhibited good interlaboratory agreement (r>0.7), while IFN-α2 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.
AB - 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-γ, 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-1β, IL-6, and IL-8, while poor agreement was seen for IFN-α2 (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-1β and IL-6 exhibited good interlaboratory agreement (r>0.7), while IFN-α2 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.
KW - Cervicovaginal secretions
KW - Cytokine measurement
KW - Microbicide studies
KW - Multiplex methods
KW - Reproducibility
UR - http://www.scopus.com/inward/record.url?scp=80053310620&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80053310620&partnerID=8YFLogxK
U2 - 10.1016/j.cyto.2011.06.011
DO - 10.1016/j.cyto.2011.06.011
M3 - Article
C2 - 21764598
AN - SCOPUS:80053310620
VL - 56
SP - 430
EP - 434
JO - Cytokine
JF - Cytokine
SN - 1043-4666
IS - 2
ER -