Perinatal

Simple, reliable perinatal testing: the Rapid fFN® test for the TLiIQ® system

Improving women’s health is a core driver behind the development of Hologic technology and products. One essential pillar in the Hologic Diagnostic Solutions portfolio is perinatal testing. Our Rapid fFN test for the TLiIQ system is a safe, reliable and noninvasive test that can help providers determine a pregnant woman’s risk of going into labor early.

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

Preterm birth is on the rise

In the United States, 1 out of 10 births are preterm.1 Globally, an estimated 15 million babies are born preterm (before 37 weeks gestation).2 Of these, nearly 1 million die each year due to complications from preterm birth.2 The preterm birth rate in the United States rose in 2015 for the first time in 8 years, where preterm birth is the leading cause of death in infants.3 Premature birth has implications for mothers and their babies. Babies born premature often need to stay in the hospital longer than babies born at term.4 Preterm birth can also lead to several long-term and sometimes lifelong complications for babies.4 With proper knowledge of preterm birth risk and provider-driven planning, many of these threats can be better managed.

A powerful predictor of preterm birth

fFN is an adhesive glycoprotein found in pregnant women that functions like a glue to bind the baby to the uterus during development.5 As a woman approaches delivery, fFN breaks down naturally and is increasingly detectable in vaginal secretions. When detected, this means that the protein is “leaking,” which can indicate that a woman is at higher risk for preterm delivery.5

The signs and symptoms of preterm labor are not reliable indicators of preterm delivery: Less than 10% of women with preterm labor symptoms deliver within 7 days.6,7 The Rapid fFN test for the TLiIQ system detects fFN in vaginal secretions through a non-invasive procedure, similar to a Pap test. fFN testing is a safe and reliable tool healthcare providers can use to help identify women who, though they may exhibit preterm birth symptoms, may be at decreased risk for delivery.

A negative fFN test result gives providers confidence that preterm labor is not imminent, as less than 1% of women with a negative test deliver within 14 days.5 A positive fFN result indicates an increased risk of delivery in the next 14 days and can help guide treatment decisions.5

The healthcare benefits of fFN testing

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

  • Timely and appropriate interventions with potential treatment such as antenatal steroid administration or avoidance of unnecessary treatments for those at lower risk.
  • Hospitalizations of only those patients with greatest risk of preterm delivery, with decreases in admissions numbers and length of stay from 4.2 to .6 days for those at lower risk.8
  • Effective transfer of preterm labor patients to higher and more appropriate levels of care.

To learn more about our Perinatal portfolio, visit fFNTest.com.


References: 1. Centers for Disease Control. Preterm Birth. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. Updated June 26, 2017. Accessed November 29, 2017.  2. World Health Organization. Preterm Birth. http://www.who.int/mediacentre/factsheets/fs363/en/. Reviewed November 2016. Accessed November 29, 2017.  3. 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. Published November 1, 2016. Accessed November 29, 2017.  4. March of Dimes. Premature Babies. http://www.marchofdimes.org/complications/premature-babies.aspx. Reviewed October 2013. Accessed November 29, 2017.  5. Rapid fFN for the TLiIQ System [package insert]. AW-04196-002, Rev. 003.  6. Tsoi E, et al. Ultrasound assessment of cervical length in threatened preterm labor. Obstet Gynecol. 2003;21(6):552-555. doi:10.1002/uog.131.  7. ACOG. How to Tell When Labor Begins. http://www.acog.org/Patients/FAQs/How-to-Tell-When-Labor-Begins. Published May 2011. Accessed November 29, 2017.  8. 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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Quantitative data for a more complete answer: the PeriLynx system

When it comes to preterm labor, establishing risk is key. Hologic perinatal technology gives healthcare providers valuable information to help manage care and influence treatment choices. When a patient’s pregnancy is high risk, quantitative data can help providers better manage care and prepare for different potential outcomes. The Rapid fFN 10Q test on the PeriLynx system gives providers a measurable data point to evaluate as part of a risk assessment. Using this and other data, providers can make better-informed decisions about which patients should be admitted to a healthcare setting, more closely observed or discharged.

More information and less guesswork with fFN testing

The Rapid fFN 10Q test on the PeriLynx system is a quantitative test that detects concentration levels of fetal fibronectin (fFN) in cervicovaginal secretions. fFN is an adhesive glycoprotein found in pregnant women that functions like a glue to bind the baby to the uterus during development, and it is a key indicator of preterm labor in women experiencing signs and symptoms of preterm labor.1 As a woman approaches delivery, fFN breaks down naturally and is increasingly detectable in vaginal secretions.1 This means that when fFN is present in certain concentrations, a woman may be close to labor.1 The Rapid fFN 10Q test on the PeriLynx system allows providers to give women who are at low risk of preterm labor peace of mind in knowing that they are unlikely to deliver early. For women whose fFN results indicate high risk of preterm labor, providers are given an opportunity to reevaluate and possibly alter patient management. The Rapid fFN 10Q test on the PeriLynx system is a fast and easy-to-administer test that can help pregnant women and their providers feel more prepared in the face of preterm labor.

To learn more about our Perinatal portfolio, visit fFNTest.com.


References: 1.  Kiefer DG. The Utility of Fetal Fibronectin in the Prediction and Prevention of Spontaneous Preterm Birth. Rev Obstet Gynecol. 2008;1(3):106-112.
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