The fFN test is the only named biomarker test recommended in the NICE guidelines for the risk assessment of preterm labour and birth¹ and comes with a strong body of evidence supporting its use in the clinical setting.
A clinically proven, powerful indicator for planning and peace of mind
Quantitive Fetal Fibronectin testing (Rapid fFN® Test) has been shown to precisely measure the concentration of the fFN protein to help quantify the risk of preterm labour and birth in both patients who have symptoms of preterm labour and those at high-risk².
Studies
Please find below a PDF that compiles all the relevant studies into one easy to reference format. Please click on the image to open the PDF which contains links to the research papers.
More recently, the QUIDS Study has been published and QUIDS2 is available via the NIHR Report.
Please see below for our QUIDS Clinical Study Overview (click image for full PDF).
The fFN test is the only named biomarker test recommended in the National Institute for Health and Care Excellence (NICE) clinical guidelines for the risk assessment of preterm labour and birth.³
The British Association of Perinatal Medicine have endorsed the use of the QUiPP App in association with quantitative Fetal Fibronectin Testing and provided the Toolkit for implementation as part of their wider Antenatal Optimisation Toolkit.
The NICE guidelines for preterm labour and birth encourage fFN testing to be considered to determine the likelihood of birth within 48 hours for women who are >30 weeks pregnant.³
Further guidelines on the use of biomarker tests to help diagnose preterm labour in women concluded that for women who present at 30 weeks or above, the most appropriate comparator was fFN at a threshold of 50 nanograms/millilitre (ng/ml). For women who present at less than 30 weeks, a treat-all management pathway and fFN testing should be considered to reflect variation in current practice.⁴
A COVID-19 update to the Saving Babies Lives Care Bundle’ Version Two stated that the diagnosis of preterm labour can be optimised with the use of quantitative fetal fibronectin, and algorithms such as the QUiPP app*.⁵
In relation to women at high risk of preterm labour, as part of the Saving Babies Lives’ Version Two (Appendix 5) it confirms that providers must have provision for care for women at risk of preterm birth ideally within a preterm birth prevention clinic with midwifery support and access to screening tests, including transvaginal cervix scanning and quantitative fetal fibronectin and potential interventions, for example, cervical cerclage, pessary and progesterone. ⁶
You can download the relevant NICE resources below to learn more.
Appendix I: Implications of COVID-19 on reducing preterm births
Version 1 (June 2020)
Saving Babies’ Lives Version Two (Element 5) (March 2019)
Biomarker tests to help diagnose preterm labour in women with intact membranes
NICE Guidance (July 2018)
Preterm labour and birth
NICE Guideline (November 2015)
The QUiPP App*
The QUiPP App is a third party decision support tool that uses medical history and quantitative fetal fibronectin or cervical length to give an individualised score for the risk of having a spontaneous preterm delivery.
The QUiPP App is not a Hologic product. Hologic makes no warranties, express or implied, with respect to this product. Please reach out to QUiPP and QUiPP App Toolkit for further information.
Predicting and Preventing Premature Birth
Webinars
Webinar: How the QUiPP App can help you triage women in threatened preterm labour
– Naomi Carlisle – Senior Research Midwife in Preterm Birth, King’s College London (July 2020)
Symposiums
Symposium: Reducing Preterm Birth – UK Preterm Birth Clinical Network Specification Recommendations
– Professor Anna David, Consultant in Obstetrics and Maternal Fetal Medicine, UCLH, BMFMS (2018)
Symposium: Use of quantitative fFN in symptomatic and asymptomatic women: our view on best practice
– Dr Manju Chandiramani, Consultant Obstetrician, Guys and St Thomas’ NHS Foundation Trust, BMFMS (2018)
PDF Documents – Please click on the link to download the PDF document.
Rapid fFN® PeriLynx Quick Reference Guide
Rapid fFN® 10Q Cassette Kit Package Insert
Rapid fFN® Test Specimen Collection Kit Package Insert
Rapid fFN® Control Kit Package Insert
Videos
Quantitative Fetal Fibronectin Test: An Overview
Quantitative Fetal Fibronectin Test: Collection and Analysis
Quantitative Fetal Fibronectin Test: Installation of Your Perilynx Analyser
Quantitative Fetal Fibronectin Test: Looking After Your Perilynx Analyser
* Developed by the QUiPP App Toolkit Group© (Ms Naomi Carlisle, Dr Ellie Watson & Professor Andrew Shennan) at King’s College London, and Guy’s and St Thomas’ NHS Foundation Trust. Hologic makes no warranties, express or implied, with respect to this third party product. For more information please visit QUiPP Clinician Tool and QUiPP App Toolkit
References
- National Institute for Health and Care Excellence (NICE). Preterm labour and birth guidance. Published November 2015. Available at: NICE Preterm Labour for Women
- AW-29098-001_003 – 10Q Cassette Product Insert
- National Institute for Health and Care Excellence (NICE). Preterm labour and birth guidance. Published November 2015. Available at: NICE Preterm Labour for Women
- National Institute for Health and Care Excellence (NICE). Biomarker tests to help diagnose preterm labour in women with intact membranes. Published July 2018. Available at: NICE Biomarker Testing
- Appendix I: Implications of COVID-19 on reducing preterm births – NHS Saving Babies Care Bundle
- NHS England Saving Babies Lives Version Two. Published in 2019. NHS Saving Babies (Version Two)