Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?

We assessed the influence of external factors on false-positive, false-negative, and invalid fibronectin results in the prediction of spontaneous delivery within 7 days.  We studied symptomatic women between 24 and 34 weeks' gestational age. We performed uni- and multivariable logistic regressi...

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Published in:American journal of perinatology Vol. 34; no. 3; p. 234
Main Authors: Bruijn, Merel M C, Hermans, Frederik J R, Vis, Jolande Y, Wilms, Femke F, Oudijk, Martijn A, Kwee, Anneke, Porath, Martina M, Oei, Guid, Scheepers, Hubertina C J, Spaanderman, Marc E A, Bloemenkamp, Kitty W M, Haak, Monique C, Bolte, Antoinette C, Vandenbussche, Frank P H A, Woiski, Mallory D, Bax, Caroline J, Cornette, Jérôme M J, Duvekot, Johannes J, Bijvank, Bas W A N I J, van Eyck, Jim, Franssen, Maureen T M, Sollie, Krystyna M, van der Post, Joris A M, Bossuyt, Patrick M M, Kok, Marjolein, Mol, Ben W J, van Baaren, Gert-Jan
Format: Journal Article
Language:English
Published: United States 01-02-2017
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Summary:We assessed the influence of external factors on false-positive, false-negative, and invalid fibronectin results in the prediction of spontaneous delivery within 7 days.  We studied symptomatic women between 24 and 34 weeks' gestational age. We performed uni- and multivariable logistic regression to estimate the effect of external factors (vaginal soap, digital examination, transvaginal sonography, sexual intercourse, vaginal bleeding) on the risk of false-positive, false-negative, and invalid results, using spontaneous delivery within 7 days as the outcome.  Out of 708 women, 237 (33%) had a false-positive result; none of the factors showed a significant association. Vaginal bleeding increased the proportion of positive fetal fibronectin (fFN) results, but was significantly associated with a lower risk of false-positive test results (odds ratio [OR], 0.22; 95% confidence intervals [CI], 0.12-0.39). Ten women (1%) had a false-negative result. None of the investigated factors was significantly associated with a significantly higher risk of false-negative results. Twenty-one tests (3%) were invalid; only vaginal bleeding showed a significant association (OR, 4.5; 95% CI, 1.7-12).  The effect of external factors on the performance of qualitative fFN testing is limited, with vaginal bleeding as the only factor that reduces its validity.
ISSN:1098-8785
DOI:10.1055/s-0036-1585466