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

Merel M. C. Bruijn; Frederik J. R. Hermans; Jolande Y. Vis; Femke Wilms; Martijn A. Oudijk; Anneke Kwee; Martina Porath; Guid Oei; Hubertina C. J. Scheepers; Marc E. A. Spaanderman; Kitty W. M. Bloemenkamp; Monique C. Haak; Antoinette C. Bolte; Frank P. H. A. Vandenbussche; Mallory D. Woiski; Caroline J. Bax; Jerome M. J. Cornette; Johannes Duvekot; Bas W. A. N. I. J. Bijvank; Jim van Eyck; Maureen T. M. Franssen; Krystyna M. Sollie; Joris A. M. van der Post; Patrick M. Bossuyt; Marjolein Kok; Ben W. J. Mol; Gert-Jan van Baaren

doi:10.1055/s-0036-1585466

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

Merel M. C. Bruijn^*, Frederik J. R. Hermans, Jolande Y. Vis, Femke Wilms, Martijn A. Oudijk, Anneke Kwee, Martina Porath, Guid Oei, Hubertina C. J. Scheepers, Marc E. A. Spaanderman, Kitty W. M. Bloemenkamp, Monique C. Haak, Antoinette C. Bolte, Frank P. H. A. Vandenbussche, Mallory D. Woiski, Caroline J. Bax, Jerome M. J. Cornette, Johannes Duvekot, Bas W. A. N. I. J. Bijvank, Jim van EyckMaureen T. M. Franssen, Krystyna M. Sollie, Joris A. M. van der Post, Patrick M. Bossuyt, Marjolein Kok, Ben W. J. Mol, Gert-Jan van Baaren

^*Corresponding author for this work

Reproductive Origins of Adult Health and Disease (ROAHD)

Research output: Contribution to journal › Article › Academic › peer-review

4 Citations (Scopus)

Abstract

Objective 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.

Methods 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.

Results 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).

Conclusion 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.

Original language	English
Pages (from-to)	234-239
Number of pages	6
Journal	American Journal of Perinatology
Volume	34
Issue number	3
DOIs	https://doi.org/10.1055/s-0036-1585466
Publication status	Published - Feb-2017

Keywords

fetal fibronectin
preterm delivery
prediction
external factors
MISSING VALUES
PHARMACOKINETICS
IMPUTATION
FDC-6

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Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?
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Bruijn, M. M. C., Hermans, F. J. R., Vis, J. Y., Wilms, F., Oudijk, M. A., Kwee, A., Porath, M., Oei, G., Scheepers, H. C. J., Spaanderman, M. E. A., Bloemenkamp, K. W. M., Haak, M. C., Bolte, A. C., Vandenbussche, F. P. H. A., Woiski, M. D., Bax, C. J., Cornette, J. M. J., Duvekot, J., Bijvank, B. W. A. N. I. J., ... van Baaren, G.-J. (2017). Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor? American Journal of Perinatology, 34(3), 234-239. https://doi.org/10.1055/s-0036-1585466

@article{df5ce1090df94bebbea3b0b92acf37f7,

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

abstract = "Objective 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.Methods 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.Results 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).Conclusion 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.",

keywords = "fetal fibronectin, preterm delivery, prediction, external factors, MISSING VALUES, PHARMACOKINETICS, IMPUTATION, FDC-6",

author = "Bruijn, {Merel M. C.} and Hermans, {Frederik J. R.} and Vis, {Jolande Y.} and Femke Wilms and Oudijk, {Martijn A.} and Anneke Kwee and Martina Porath and Guid Oei and Scheepers, {Hubertina C. J.} and Spaanderman, {Marc E. A.} and Bloemenkamp, {Kitty W. M.} and Haak, {Monique C.} and Bolte, {Antoinette C.} and Vandenbussche, {Frank P. H. A.} and Woiski, {Mallory D.} and Bax, {Caroline J.} and Cornette, {Jerome M. J.} and Johannes Duvekot and Bijvank, {Bas W. A. N. I. J.} and {van Eyck}, Jim and Franssen, {Maureen T. M.} and Sollie, {Krystyna M.} and {van der Post}, {Joris A. M.} and Bossuyt, {Patrick M.} and Marjolein Kok and Mol, {Ben W. J.} and {van Baaren}, Gert-Jan",

year = "2017",

month = feb,

doi = "10.1055/s-0036-1585466",

language = "English",

volume = "34",

pages = "234--239",

journal = "American Journal of Perinatology",

issn = "0735-1631",

publisher = "THIEME MEDICAL PUBL INC",

number = "3",

}