Professional Resources

FAQs, publications and additional resources regarding the Rapid fFN® test.


Publications


Antenatal steroids

2023, Razaz
Antenatal Corticosteroid Prophylaxis at Late Preterm Gestation: Clinical Guidelines Versus Clinical Practice
2023, Duncan
Antenatal Corticosteroids-is timing everything
2022, SMFM
Society for Maternal-Fetal Medicine Special Statement: Quality metrics for optimal timing of antenatal corticosteroid administration
2022, AJOG
Updating the balance between benefits and harms of antenatal corticosteroids
2022, BJOG
Antenatal corticosteroids to reduce neonatal morbidity and mortality
2022, Duncan
Use of Antenatal Corticosteroids for Risk of Preterm Birth—Is Timing Everything?
2022, Ninan
Evaluation of Long-term Outcomes Associated With Preterm Exposure to Antenatal Corticosteroids
2021, McKinzie
Are newborn outcomes different for term babies who were exposed to antenatal corticosteroids?
2021, van der Merwe
Neurocognitive sequelae of antenatal corticosteroids in a late preterm rabbit model
2020, Asztalos
A Growing Dilemma: Antenatal Corticosteroids and Long-Term Consequences
2020, Räikkönen
Associations Between Maternal Antenatal Corticosteroid Treatment and Mental and Behavioral Disorders in Children
2020, Whitelaw
Antenatal steroids and the developing brain
2019, ACOG
Clinical Guidelines and Standardization of Practice to Improve Outcomes
2019, Melamed
Neurodevelopmental disorders among term infants exposed to antenatal corticosteroids during pregnancy: a population-based study
2015, Wilms
Prescribing Patterns of Antenatal Corticosteroids in Women with Threatened Preterm Labor
2015, Razaz
Trends in Optimal, Suboptimal, Questionably Appropriate Receipt of Antenatal Corticosteroid Prophylaxis
2014, Asztalos
Association between gestational age at birth,antenatal corticosteroids, and outcomes at 5 years: multiple courses of antenatal corticosteroids for preterm birth study at 5 years of age (MACS-5)
2011, Wilms
Relationship Between the Time Interval from Antenatal Corticosteroid Administration Until Preterm Birth and the Occurrence of Respiratory Morbidity
2002, Honest
Accuracy of Cervicovaginal Fetal Fibronectin Test in Predicting Risk of Spontaneous Preterm Birth: Systematic Review

General fFN Studies

2017, Ruma
Current Perspectives on the Use of Fetal Fibronectin Testing in Preterm Labor Diagnosis and Management
2017, McCue
Fetal Fibronectin: The Benefits of a High Negative Predictive Value in Management of Preterm Labor
2017, Blackwell
Utilization of Fetal Fibronectin Testing and Pregnancy Outcomes Among Women with Symptoms of Preterm Labor
2009, How
Cervical Dilatation on Presentation for Preterm Labor and Subsequent Preterm Birth
2001, Lockwood
Risk Stratification and Pathological Mechanisms in Preterm Delivery
2000, Goldenberg
The Preterm Prediction Study: Sequential Cervical Length and Fetal Fibronectin Testing for the Prediction of Spontaneous Preterm Birth
1998, Lams
The Preterm Prediction Study: Recurrence Risk of Spontaneous Preterm Birth
1997, Peaceman
Fetal Fibronectin as a Predictor of Preterm Birth in Patients with Symptoms: A Multicenter Trial
1997, Goldenberg
The Preterm Prediction Study: Patterns of Cervicovaginal Fetal Fibronectin as Predictors of Spontaneous Preterm Delivery

TVUS + fFN

2018, Chiossi
Using Cervical Length Measurement for Lower Spontaneous Preterm Birth Rates Among Women with Threatened Preterm Labor
2017, Boelig
Assessment of Transvaginal Ultrasound Cervical Length Image Quality
2016, Chory
ACES: Accurate Cervical Evaluation with Sonography
2015, Hermans
Risk Stratification with Cervical Length and Fetal Fibronectin in Women with Threatened Preterm Labor before 34 Weeks and Not Delivering within 7 Days
2014, Parry
Pros and Cons of Maternal Cervical Length Screening to Identify Women at Risk of Spontaneous Preterm Delivery
2013, Van Baaren
Cost-Effectiveness Analysis of Cervical Length Measurement and Fibronectin Testing in Women with Threatened Preterm Labor
2013, Iams
Adherence to Criteria for Transvaginal Ultrasound Imaging and Measurement of Cervical Length
2013, DeFranco
Improving the Screening Accuracy for Preterm Labor: Is the Combination of Fetal Fibronectin and Cervical Length in Symptomatic Patients a Useful Predictor of Preterm Birth? A Systematic Review
2008, Schmitz
Selective Use of Sonographic Cervical Length Measurement for Predicting Imminent Preterm Delivery in Women with Preterm Labor and Intact Membranes
2005, Gomez
Cervicovaginal Fibronectin Improves the Prediction of Preterm Delivery Based on Sonographic Cervical Length in Patients with Preterm Uterine Contractions and Intact Membranes
2000, Goldenberg
The Preterm Prediction Study: Sequential Cervical Length and Fetal Fibronectin Testing for the Prediction of Spontaneous Preterm Birth

Clinical Assessment

2021 Plos
Evaluating the use of the QUiPP app and its impact on the management of threatened preterm labour: A cluster randomised trial
2009 How
Cervical dilatation on presentation for preterm labor and subsequent preterm birth.
1998, Goldenberg
The Preterm Prediction Study: The Value of New vs. Standard Risk Factors in Predicting Early and All Spontaneous Preterm Births
1995, Phelps
Accuracy and Intraobserver Variability of Simulated Cervical Dilatation Measurements
1994, Iams
Fetal Fibronectin Improves the Accuracy of Diagnosis of Preterm Labor

Standardization & cost savings

2013, Van Baaren
Cost-Effectiveness Analysis of Cervical Length Measurement and Fibronectin Testing in Women with Threatened Preterm Labor
2013, Lucovnik
Cost of Unnecessary Admissions and Treatments for “Threatened PTL”
2013, Iyer
The association of fFN testing on hospital admissions for preterm labor
2010, Rose
Cost-Effective Standardization of Preterm Labor Evaluation
2010, Dutta
The Efficacy of Fetal Fibronectin Testing in Minimising Hospital Admissions, Length of Hospital Stay and Cost Savings in Women Presenting with Symptoms of Pre-Term Labour
2006, Ness
Impact of the Recent Randomized Trials on the Use of Progesterone to Prevent Preterm Birth: A 2005 Follow-Up Survey
2000, Giles
The Effect of Fetal Fibronectin Testing on Admissions to a Tertiary Maternal Fetal Medicine Unit and Cost Savings
1999, Joffe
Impact of Fetal Fibronectin Assay on Admissions for Preterm Labor

Twins

2018, Fuchs
Accuracy of Fetal Fibronectin for the Prediction of Preterm Birth in Symptomatic Twin Pregnancies: A Pilot Study
2007, Singer
Accuracy of Fetal Fibronectin to Predict Preterm Birth in Twin Gestations with Symptoms of Labor


fFN Videos


fFN testing fundamentals

fFN ≠ ROM testing.
Different tests. Different purposes.

Collecting an fFN specimen

Creating a PTL protocol to improve outcomes

Free educational resources & materials

On-Demand In-Service Presentation


Test your knowledge


Think you know everything there is to know about fFN testing?
Take this quick 6 question true/false quiz and find out.

1.

A negative fFN result is valid even if
she’s had sex in the prior 24 hours.

2.

~80% of patients will get
a negative fFN result.

3.

Collection window for symptomatic patients: 240 – 346 weeks.

4.

fFN must be collected before
a digital exam.

5.

AmniSure, ROM Plus®, and Actim PROM tests can be used instead of fFN testing.

AmniSure is a trademark of QIAGEN Group.

ROM Plus is a trademark of Clinical Innovations.

Actim PROM is a trademark of Cooper Surgical

6.

Using fFN in addition to TVUS improves sPTB prediction by ~50% vs. TVUS alone.

1.Correct!

A negative fFN result is valid after sex.

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

Rapid fFN for the TLiIQ System [package insert]. AW-04196-001, 004, Sunnyvale, CA: Hologic, Inc.; 2017.

1.Incorrect!

A negative fFN result is valid after sex.

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

Rapid fFN for the TLiIQ System [package insert]. AW-04196-001, 004, Sunnyvale, CA: Hologic, Inc.; 2017.

2.Correct!

~80% of patients will receive a
negative fFN test result.

The vast majority of symptomatic patients,
~80%, will receive a negative result.

Rapid fFN for the TLiIQ System [package insert]. AW-04196-001, 004, Sunnyvale, CA: Hologic, Inc.; 2017.

2.Incorrect!

~80% of patients will receive a
negative fFN test result.

The vast majority of symptomatic patients,
~80%, will receive a negative result.

Rapid fFN for the TLiIQ System [package insert]. AW-04196-001, 004, Sunnyvale, CA: Hologic, Inc.; 2017.

3.Correct!

24 weeks, 0 days – 34 weeks, 6 days.

That’s the FDA approved gestational collection window
for patients with symptoms of preterm labor.

Rapid fFN for the TLiIQ System [package insert]. AW-04196-001, 004, Sunnyvale, CA: Hologic, Inc.; 2017.

3.Incorrect!

24 weeks, 0 days – 34 weeks, 6 days.

That’s the FDA approved gestational collection window
for patients with symptoms of preterm labor.

Rapid fFN for the TLiIQ System [package insert]. AW-04196-001, 004, Sunnyvale, CA: Hologic, Inc.; 2017.

4.Correct!

Always collect an fFN specimen first; there are no 2nd chances.

Always collect an fFN sample before a digital exam.
Collection kits are free and you can always decide later to send the sample for testing, but you can’t decide later to collect a sample.

Rapid fFN for the TLiIQ System Specimen Collection Kit [instructions for use]. AW-04194. Sunnyvale, CA; Hologic, Inc.: 2017

4.Incorrect!

fFN, Actim PROM, ROM Plus®, and
Amni Sure are different tests and can NOT be
used as substitutes.

Always collect an fFN sample before a digital exam.
Collection kits are free and you can always decide later to send the sample for testing, but you can’t decide later to collect a sample.

Rapid fFN for the TLiIQ System Specimen Collection Kit [instructions for use]. AW-04194. Sunnyvale, CA; Hologic, Inc.: 2017

5.Incorrect!

fFN Testing ≠ ROM Testing

fFN testing detects fetal fibronectin, the “glue” that holds the baby to the mother, it is used to help assess the risk of preterm birth. ROM testing detects amniotic fluid in vaginal secretions. If amniotic fluid is present in vaginal secretions, there is a high probability of a ruptured fetal membrane.1,2

1. Rapid fFN for the TLiIQ System [package insert]. MAN-01669-001, Rev. 003. San Diego, CA: Hologic, Inc.; 2018. 2. Aetna. Non-Invasive Fetal Membranes Rupture Tests. Clinical Policy Bulletin 0757. Last Reviewed November 6, 2020. Accessed January 21, 2021. http://www.aetna.com/cpb/medical/data/700_799/0757.html#:

5.Correct!

fFN Testing ≠ ROM Testing

fFN testing detects fetal fibronectin, the “glue” that holds the baby to the mother, it is used to help assess the risk of preterm birth. ROM testing detects amniotic fluid in vaginal secretions. If amniotic fluid is present in vaginal secretions, there is a high probability of a ruptured fetal membrane.1,2

1. Rapid fFN for the TLIIQ System [package insert]. MAN-01669-001, Rev. 003. San Diego, CA: Hologic, Inc.; 2018. 2. Aetna. Non-Invasive Fetal Membranes Rupture Tests. Clinical Policy Bulletin 0757. Last Reviewed November 6, 2020. Accessed January 21, 2021. http://www.aetna.com/cpb/medical/data/700_799/0757.html#:

6.Correct!

Using fFN in addition to TVUS improves
sPTB prediction by ~50% vs. TVUS alone.

1 out of 4 patients with a cervical length (CL) measurement of <30mm will deliver <7 days.
However, when a patient with a <30mm CL also has a positive fFN result, her risk increases to ~1 out of 2. And if she has a <30mm CL and a negative fFN result, her risk drops to just ~1 out of 10.

R. Gomez, et al. Cervicovaginal fibronectin improves the prediction of preterm delivery based on sonographic cervical length in patients with preterm uterine contractions and intact membranes. AJOG 2005; 192: 350-359.

6.Incorrect!

Using fFN in addition to TVUS improves
sPTB prediction by ~50% vs. TVUS alone.

1 out of 4 patients with a cervical length (CL) measurement of <30mm will deliver <7 days.
However, when a patient with a <30mm CL also has a positive fFN result, her risk increases to ~1 out of 2. And if she has a <30mm CL and a negative fFN result, her risk drops to just ~1 out of 10.

R. Gomez, et al. Cervicovaginal fibronectin improves the prediction of preterm delivery based on sonographic cervical length in patients with preterm uterine contractions and intact membranes. AJOG 2005; 192: 350-359.

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Frequently asked questions


What is Fetal Fibronectin?

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

Where is the Rapid fFN® test used?

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

Which patients can receive a Rapid fFN® test?

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

When can the test be performed?

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

Why is the test performed?

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.

How is the specimen collected?

  • 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

What are contraindications for collecting/sending a specimen for an fFN test?

  • 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

Can I collect a specimen if the patient has had sex in the last 24 hours?

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

How are fFN results interpreted?

  • 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

How many patients will receive a negative result?

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

Can I use an AmniSure®, ROM Plus®, or Actim PROM® test instead of an fFN test to rule out imminent preterm birth?

  • 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.

How long does it take to run the test?

  • 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).

How long is the specimen viable?

  • 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.

What does an fFN test cost?

  • 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.

Package inserts and IFUs


To view the instructions for use, click the link below.


Assess preterm birth risk with the Rapid fFN test


Contact us for more information about Rapid fFN®.


Assess preterm birth risk with the Rapid fFN test


Contact us for more information about Rapid fFN® test.