Perinatal

Simple, reliable testing to assess a patient’s risk of preterm birth: The Rapid fFN® test.

Improving women’s health is at the core of Hologic’s technology and products. One essential pillar in the Hologic Diagnostic Solutions portfolio is perinatal testing. The Rapid fFN test is a safe, reliable, and non-invasive test that can help providers determine a pregnant woman’s risk of delivering preterm.

The use of fetal fibronectin (fFN) testing can help reduce unnecessary admissions and hospitalizations and help direct care and resources to patients who need it most.

Preterm birth is on the rise

Preterm birth is defined as a birth before 37 weeks gestation. In the United States, 1 out of 10 births are preterm. The preterm birth rate in the United States has been rising in recent years and preterm birth is the leading cause of death in infants.2 Additionally, babies born prematurely may have more health problems at birth than babies born at term.3 While some problems of preterm birth can be treated, others can cause long-term developmental problems or learning disabilities.4 With proper knowledge of preterm birth risk and provider-driven planning, many of these threats can be better managed.

Fetal Fibronectin: A powerful predictor of preterm birth

fFN is an adhesive glycoprotein found at the maternal-fetal interface which functions like a glue to bind the baby to the uterus during fetal development.5 fFN is generally absent in vaginal secretions during weeks 16 to 35 of gestation, so if fetal fibronectin is detectable in vaginal discharge during pregnancy weeks 22-35, it means that the protein is “leaking.” This can alert healthcare providers that the patient is at risk of preterm birth.5  Likewise, the absence of fFN is very reassuring, because even if a patient is experiencing symptoms of preterm labor such as contractions or cramping, a negative fFN test indicates a less than 1% risk of delivery in the next 14 days.5 

True preterm labor is very difficult to diagnose. In fact, only about 10% of women with a clinical diagnosis of preterm labor actually go on to deliver within 7 days.6 fFN testing is an objective tool that can help healthcare providers identify which women with symptoms of preterm labor are at very low risk of an imminent preterm delivery and can safely be discharged and which are at higher risk and should be admitted and receive interventions.

The Rapid fFN test is FDA approved for use in symptomatic patients between 240 and 346 weeks gestation and for asymptomatic patients between 220 and 306 weeks gestation.5

A negative fFN test result helps give healthcare providers confidence that preterm birth is not imminent. And a positive fFN test result offers multiple benefits as well, including opportunities to better manage care for patients who are at increased risk for preterm delivery, and helps ensure critical interventions are administered. 

The healthcare benefits of fFN testing

The Rapid fFN test is one of several tools that help providers determine the best course of action for patients with symptoms of preterm labor. Benefits of fFN testing include increased efficiencies, without compromising clinical outcomes. These benefits are achieved through:

  • Timely and appropriate interventions, such as antenatal steroids and magnesium sulfate, and likewise avoidance of unnecessary interventions for those at lower risk.
  • Avoidance of unnecessary hospitalizations. One study showed that the average length of stay for patients with symptoms of preterm labor was reduced from 5.2 days to just 0.6 days after fFN testing was adopted.7
  • Effective transfer of patients at high risk of imminent preterm birth to a hospital with an appropriate NICU. 

To learn more about the Rapid fFN test, visit fFNTest.com.


References: 1. Centers for Disease Control. Preterm Birth. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. Updated June 26, 2017. Accessed May 21, 2020. 2. March of Dimes. Preterm Birth Increases in the U.S. For The First Time in Eight Years. http://www.marchofdimes.org/news/preterm-birth-increases-in-the-us-for-the-first-time-in-eight-years.aspx. Accessed May 21, 2020. 3. March of Dimes. Long-Term Health Effects of Premature Birth. https://www.marchofdimes.org/complications/long-term-health-effects-of-premature-birth.aspx Reviewed October 2013. Accessed May 21, 2020. 4. March of Dimes. Premature Babies. http://www.marchofdimes.org/complications/premature-babies.aspx. Reviewed October 2013. Accessed May 21, 2020.  5. Rapid fFN for the TLiIQ System [package insert]. AW-04196-002, Rev. 004.  6. ACOG. Preterm Labor and Birth. https://www.acog.org/patient-resources/faqs/labor-delivery-and-postpartum-care/preterm-labor-and-birth. Accessed May 21, 2020.  7. Abenhaim HA, et al. Does availability of fetal fibronectin testing in the management of threatened preterm labour affect the utilization of hospital resources? J Obstet Gynaecol Can. 2005;27(7):689-94. doi:10.1016/S1701-2163(16)30547-3.

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Preterm birth is a serious problem

Preterm birth is defined as delivery before 37 weeks gestation. Globally, an estimated 15 million babies are born prematurely. Preterm birth complications are the leading cause of death among children under five years of age, resulting in nearly one million deaths each year.

Babies born prematurely may have more health problems at birth than babies born at term.2 While some problems related to preterm birth can be treated, others can cause long-term developmental problems or learning disabilities.3 With proper knowledge of preterm birth risk and appropriate healthcare professional planning, many of these threats can be better managed.

Quantitative data for a more complete answer: the PeriLynxTM System

When it comes to preterm birth, establishing the risk of delivery is key. Hologic’s quantitative Rapid fFN Test on the PeriLynx System gives healthcare professionals valuable information in a matter of minutes.  This information can be used with other clinical information to help manage care and determine treatment choices for patients who are either experiencing symptoms of preterm delivery or for asymptomatic patients who meet the high risk criteria, such as women who have had a previous preterm delivery or women who are carrying twins or triplets.

Obtaining quantitative fetal fibronectin (fFN) data ultimately helps healthcare professionals stratify a patient’s individual risk for preterm birth, which assists with the development of a suitable management plan. Using this and other diagnostic data, allows healthcare professionals to make better-informed decisions about which patients should be admitted for treatment, observed for further diagnosis, transferred to a specialist hospital or discharged.

More information and less guesswork with quantitative fFN testing

The quantitative Rapid fFN test precisely measures the fFN concentration in cervicovaginal secretions, providing healthcare professionals with an indication of the risk of preterm birth based on the fFN measurement in ng/mL. 

Fetal fibronectin (fFN) is a "glue-like" protein that binds the membranes around the baby to the uterus. It is detectable in vaginal secretions at the very beginning of pregnancy, when this bond is first forming, and then again at the end of pregnancy.4 fFN is generally absent in vaginal secretions during weeks 16 to 35 of gestation, so if it is detected during this time, it means that the protein is “leaking”. This can alert healthcare professionals that the patient is at risk of preterm birth.4  

The quantitative Rapid fFN test allows healthcare professionals to give women who are at low risk of preterm birth peace of mind in knowing that they are unlikely to deliver in the next 7 or 14 days. For women whose fFN results indicate a high risk of preterm birth, healthcare professionals can intervene early to provide optimal patient care. 

The quantitative Rapid fFN test is approved for collection between 22-36 weeks with symptomatic patients and 18-28 weeks with asymptomatic high-risk patients.

The healthcare benefits of quantitative fFN testing

The quantitative Rapid fFN test is one of several tools available to help healthcare professionals determine the best course of action for patients with symptoms of preterm labor. Benefits of fFN testing include increased efficiencies, without compromising clinical outcomes. These benefits are achieved through:

  • Timely and appropriate interventions, such as antenatal steroids and magnesium sulphate, and likewise avoidance of unnecessary interventions or transfers for those at lower risk.
  • Avoidance of unnecessary hospitalizations. One study showed that the average length of stay for patients with symptoms of preterm labor was reduced from 5.2 days to just 0.6 days after fFN testing was adopted.5

Effective transfer of patients at high risk of imminent preterm birth to a hospital with an appropriate NICU.


References: 1. World Health Organization. Preterm Birth. http://www.who.int/mediacentre/factsheets/fs363/en/. Reviewed November 2016. Accessed May 21, 2020. 2. March of Dimes. Long-Term Health Effects of Premature Birth. https://www.marchofdimes.org/complications/long-term-health-effects-of-premature-birth.aspx. Reviewed October 2013. Accessed May 21, 2020. 3. March of Dimes. Long-Term Health Effects of Premature Birth. https://www.marchofdimes.org/complications/long-term-health-effects-of-premature-birth.aspx. Reviewed October 2013. Accessed May 21, 2020. 4. Rapid fFN 10Q Cassette [package insert], AW-09189-001-003-01, Marlborough, MA: Hologic, Inc.; 2015. 5. Abenhaim HA, et al. Does availability of fetal fibronectin testing in the management of threatened preterm labour affect the utilization of hospital resources? J Obstet Gynaecol Can. 2005;27(7):689-94. doi:10.1016/S1701-2163(16)30547-3.
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