Clinical Chemistry
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Clinical Chemistry 53: 1534-1540, 2007. First published June 7, 2007; 10.1373/clinchem.2007.084798
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(Clinical Chemistry. 2007;53:1534-1540.)
© 2007 American Association for Clinical Chemistry, Inc.

Pediatric Clinical Chemistry

Diagnostic Accuracy of Cervicovaginal Interleukin-6 and Interleukin-6:Albumin Ratio as Markers of Preterm Delivery

Alison Woodworth1,2, Jennifer Moore2, Christopher G’Sell1, Abraham Verdoes1, Jennifer A. Snyder3, Lee Morris3, Catherine Wares3, David G. Grenache3 and Ann M. Gronowski1,a

1 Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO.
2 Barnes-Jewish Hospital, St. Louis, MO.
3 Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.

aAddress correspondence to this author at: Department of Pathology and Immunology, Washington University School of Medicine, Box 8118, 660 S. Euclid, St. Louis, MO 63110. Fax 314-362-1461; e-mail gronowski{at}wustl.edu.

Background: Absence of fetal fibronectin (fFN) in the cervicovaginal fluid (CVF) of women with symptoms of preterm labor is an excellent predictor of women who will not deliver within 2 weeks of testing. Preliminary studies suggest interleukin (IL)-6 performs similarly to fFN. The positive predictive values of both these assays are poor. Inconsistent specimen collection may explain this poor performance. The objective of this study was to validate the clinical utility of cervicovaginal IL-6 and investigate the utility of the IL-6:albumin ratio to predict delivery within 14 days.

Methods: We quantified albumin and IL-6 with the DPC Immulite® in 660 CVF specimens collected for physician-ordered fFN analysis. The clinical utility of IL-6 and IL-6:albumin to predict delivery within 14 days of collection was determined.

Results: The sensitivity, specificity, and positive and negative likelihood ratios for delivery within 14 days were 65%, 87%, 4.8, and 0.4, respectively, for fFN and 35%, 91%, 3.8, and 0.7 for IL-6, with a 250 ng/L cutoff. With a preterm delivery prevalence of 4.7%, positive and negative predictive values were 19% and 98%, respectively, for fFN and 16% and 97% for IL-6. The areas under the ROC curves were 0.71 and 0.51 for IL-6 and IL-6:albumin, respectively. Odds ratios for delivery within 14 days of collection were 11.8 (P <0.0001), 5.5 (P = 0.0001), and 2.4 (P = 0.06) for fFN, IL-6, and IL-6:albumin, respectively.

Conclusions: Cervicovaginal IL-6 may have utility for predicting preterm labor while offering the potential for substantial cost savings. Assay performance characteristics are not improved by normalizing IL-6 to albumin.






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