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The fFN Test

The cost of prematurity can be very high, but the cost of assessing preterm labor doesn’t have to be. When you test with the fetal fibronectin (fFN) test, you get a clinically proven predictive value that is a powerful and accurate tool for risk assessment. We know that 80% of women with threatened preterm labor can be discharged if identified and delivered at term.  Women with risk factors or symptoms of preterm labor should get tested to help provide their doctors with important information.

 

 

 

About

Why fetal fibronectin (fFN) testing can make a difference. 

A biomarker for preterm delivery, fFN is highly associated with risk of preterm delivery when present in cervicovaginal secretions.  fFN is an adhesive glycoprotein at the maternal-fetal interface. Disruption of this interface causes the release of fFN into cervical/vaginal secretions.

fFN in symptomatic patients with High NPV.1

NPV for delivery within:

  • 7 days = 99.5%
  • 14 days = 99.2%
  • Less than 37 weeks = 84.5%

Benefits of a negative test result include: less intervention, avoidance of hospitalizations, reassurance for physicians and patients.

fFN in symptomatic patients with helpful PPV

  • 7 days = 12.7%
  • 14 days = 16.7%
  • Less than 37 weeks = 44.7%

Benefits of a positive test include: identification of the group that can be targeted for intervention, opportunity for antenatal steroids, preparations for optimal neonatal care.

The fFN test can be performed simply and accurately in an office or hospital setting. Similar to the collection of a Pap test, the fFN test sample is easy to collect, and results are available in 1 to 2 hours. 

About Fetal Fibronectin (fFn)

 

TLi IQ system

The TLi IQ system utilizes a single-use, disposable cassette, to run fetal fibronectin (fFN) tests.  The TLi IQ system is an in vitro diagnostic device designed to help objectively determine a woman's risk for preterm birth during pregnancy.

Hologic's TLi IQ system offers ease of use:

  • Single-use dry chemistry Qcette.
  • Calibration code for each Qcette lot, eliminating daily liquid calibration.
  • Automatic internal quality control of analyzer and cassette with each patient test.
  • Easy-to-read quality control and test results.

Plus, the TLi IQ system requires just four easy steps:

  • Step 1: Run the reusable Qcette once a day. 
  • Step 2: Pipette 200 µL sample into the well of a Rapid fFN Qcette.
  • Step 3: Press ENTER and walk away.
  • Step 4: Read results in less than 23 minutes.

For complete instructions on running the Rapid fFN Qcette Kit on the TLi IQ system, please refer to the Product Inserts and Manual.

Instructions for use

For more information on specimen collection and the instructions for use click here.

References
  1. Peaceman AM, Andrews WW, Thorp JM, et al. Fetal fibronectin as a predictor of preterm birth in patients with symptoms: a multicenter trial. Am J Obstet Gynecol 1997:13-18.