Professional Resources

Fetal fibronectin (fFN) acts as an adhesive glycoprotein at the maternal-fetal interface¹ and is usually not detectable in vaginal secretions between 16-35 weeks.⁶ Its premature presence in vaginal secretions is a biochemical indicator of preterm birth risk. fFN is the single common biochemical marker for all 4 mechanisms of preterm birth: activation of the maternal/fetal hypothalamic-pituitary-adrenal (HPA) axis, inflammation, decidual hemorrhage and pathological uterine distention.⁷

In over 2,000 birthing hospitals across the United States.²

Patients presenting with signs or symptoms of preterm labor are eligible to receive a Rapid fFN^® test.¹
These may include:³

• Contractions every 10 minutes or more often
• Change in vaginal discharge (leaking fluid or bleeding from the vagina)
• Pelvic pressure (the feeling that your baby is pushing downward)
• Abdominal cramps with or without diarrhea
• Low, dull backache
• The Rapid fFN^® test can be used on both symptomatic singleton and twin pregnancies.¹

fFN testing is FDA approved in symptomatic patients between 24⁰ and 34⁶ weeks gestation.¹ The FDA has also
approved fFN testing for asymptomatic patients at risk of preterm delivery between 22⁰ and 30⁶ weeks gestation.¹

To determine a woman’s risk of preterm delivery in the next 7-14 days.¹ Results can be useful when trying to determine whether to admit her to the hospital and when to administer antenatal corticosteroids.

• The specimen must be collected prior to other vaginal exams, without gels or lubricants.¹
• During speculum exam, lightly rotate swab across posterior fornix of vagina for 10 seconds to absorb cervicovaginal
  secretions.¹
• Remove swab and immerse polyester tip in buffer; break shaft at score even with top of tube.¹
• Align the shaft with hole inside the tube cap and push down tightly over shaft, sealing tube; ensure shaft is aligned to avoid leakage. Write patient’s name and other identifying information required on the specimen transport tube label.¹

• Dilation > 3 cm
• Moderate or gross vaginal bleeding (spotting is OK)
• Placental abruption or placenta previa
• Rupture of membranes

If none of the above contraindications are present, it is appropriate to send the fFN sample to the lab according to instructions for use. ¹

Yes. A negative fFN result is valid even if she’s had sex in the 24 hours. Semen will not cause a false negative, but it can occasionally cause a false positive. So a positive result, in this situation, may not be valid and should be confirmed after 24 hours.⁴

• The Rapid fFN® test has an FDA-approved negative predictive value (NPV) of 99.2%, meaning that the patient has <1%
  chance of delivery with a negative result in the next 14 days.¹
• The Rapid fFN Test is the only FDA-approved test to assess the risk of preterm delivery that has both a 7 and 14-day indication.^1,4

The vast majority of patients, ~80%, will receive a negative result allowing you to focus on the 20% that really are at the highest risk.¹

• No, these are different tests with different purposes. Patients can be in active preterm labor but not yet ruptured, so a negative ROM test result does not rule out imminent preterm birth.⁵
• Leaking fFN can reveal her preterm birth risk long before her membranes actually rupture.

• Once the collected specimen arrives in the lab, it takes < 30 minutes for the TLiIQ^® analyzer to produce an fFN test result.¹
• The lab can likely provide a test result within 1 hour if the fFN sample is sent immediately (check with your
  internal process).

• The specimen can be stored at room temperature for up to 8 hours before testing or kept refrigerated for up to 3 days before testing.¹
• While an fFN sample is typically collected in L&D when a patient presents with symptoms of preterm birth, this lengthy period of viability also gives providers the flexibility to collect the fFN sample in the office prior to conducting a digital exam and then sending it with the patient to L&D.

• The cost of the Rapid fFN^® test itself is covered by many insurance policies; however, costs to patients will vary depending on their individual insurance.
• Remember to always collect an fFN specimen from each patient who presents with symptoms of preterm birth prior to doing a digital exam. If the specimen cannot be sent to the lab due to a contraindication identified later during the exam, there is NO CHARGE since the fFN collection swabs are free.