Monoclonal antibody FDC-6 exhibits binding to human plasma fibronectin: A caveat for cervicovaginal oncofetal fibronectin testing?

Abstract

Monoclonal antibody FDC-6 has been used clinically to measure cervicovaginal fibronectin and to predict patients at risk for preterm labor. Because bleeding is often a complicating factor during pregnancy, the aim of this study was to determine whether FDC-6 reactive fibronectin is present in normal human plasma. Quantitative Western immunoblots and a commercially available enzyme-linked immunosorbent assay were used to measure FDC-6 binding to nonpregnant human and bovine plasma fibronectin. FDC-6 binding to whole sera was also assessed, as was the effect of enzymatic deglycosylation of human plasma fibronectin. Both assays demonstrated measurable FDC-6-reactive fibronectin in nonpregnant human blood, with plasma concentrations ranging from 3 to 12 micrograms/ml (1% to 4% of total plasma fibronectin). FDC-6 had no detectable binding activity to bovine plasma fibronectin. De-O-glycosylated human plasma fibronectin had markedly reduced binding activity for FDC-6. FDC-6 binds specifically to a clinically significant percentage of circulating O-glycosylated human plasma fibronectin isoforms that are not associated with pregnancy. This caveat should be considered when pregnant patients are evaluated for the presence of FDC-6 reactive oncofetal fibronectin in the cervix or vagina.