Abstract
Preterm birth is an important cause of perinatal morbidity and mortality. Various biomarkers in cervicovaginal secretions related to preterm birth have been investigated, of which foetal fibronectin (fFN) shows the greatest potential because of its high negative predictive value. The immunomagnetic reduction (IMR) assay has emerged as a novel quantitative method to detect biomarkers. In this prospective case-control study, we analysed 33 samples of cervicovaginal secretions from pregnant women between 22 and 34 weeks of gestation at high risk of preterm birth. Seventeen samples were from women with term deliveries and 16 from those with preterm deliveries. The fFN concentration in each sample was measured using both an IMR assay and enzyme-linked immunosorbent assay (ELISA). The low detection limits of the IMR assay and ELISA were 0.0001 ng/mL and 0.789 ng/mL, respectively. The sensitivity and specificity of the IMR assay were 0.833 and 0.944, respectively, compared to 0.583 and 0.611 by ELISA. Our results suggest that measuring the concentration of fFN with the IMR assay is a good alternative method to accurately predict the risk of preterm birth.
Highlights
Time-consuming, and potential cross-reactions between bound antibodies can result in inaccurate colour signal intensity measurements
We investigated whether the immunomagnetic reduction (IMR) assay can be used to detect fFN concentrations in cervicovaginal secretions collected from pregnant women at high risk of preterm birth
In the IMR assay, magnetic nanoparticles coated with anti-fFN are well dispersed in phosphate buffered solution (PBS) buffer due to the homogeneous nano-size of nanoparticles
Summary
Time-consuming, and potential cross-reactions between bound antibodies can result in inaccurate colour signal intensity measurements. The IMR assay has emerged as a novel quantitative method to detect biomarkers, and it has been shown to enhance sensitivity and specificity of biomarker detection[15,16,17]. It measures the concentration of fFN by comparing changes in magnetic responses between free and conjugated magnetic nanoparticles. The preliminary results showed the possibility to assay fFN in phosphate buffered solution (PBS) via IMR technology. We investigated whether the IMR assay can be used to detect fFN concentrations in cervicovaginal secretions collected from pregnant women at high risk of preterm birth. We compared the IMR assay and ELISA in their ability to detect fFN
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