Who Should Be Tested?
The FDA has approved fFN testing, for use as an aid in assessing the risk of preterm birth in women with symptoms of preterm labor and women without symptoms (asymptomatic).
Product information for fetal fibronectin enzyme immunoassay and Rapid fFN for the TLiIQ® System.
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Women at risk with symptoms
In the pivotal clinical trial, less than 1% of symptomatic women with a negative fetal fibronectin test result delivered in the next two weeks. Almost 1 out of 2 symptomatic women with a positive test result delivered before 37 weeks.1
Women at risk without symptoms
In the NIH Preterm Prediction Study, less than 1% of women who received a negative test result delivered before 28 weeks. fFN testing detected nearly two-thirds of the preterm births that occured prior to 28 weeks.2
- 1. Peaceman AM, Andrews WW, Thorp JM, et al. Fetal fibronectin as predictor of preterm birth in patients with symptoms: A multicenter trial. Am J Obstet Gynecol. 1997;177:13-18.
- 2. Goldenberg RL, et al. The Preterm Prediction Study: Fetal fibronectin testing and spontaneous preterm birth. Obstet Gynecol. 1996;87:643-8.