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Frequently Asked Questions

Fetal fibronectin (fFN) is a “glue-like” protein that helps bond the baby to the uterus.

 

Fetal fibronectin is detectable in vaginal secretions in the very beginning of pregnancy, when this bond is first forming and then again at the end of pregnancy, when the body is getting ready to deliver the baby. If fetal fibronectin is detectable in vaginal discharge between 22 and 35+6 weeks in symptomatic women¹, this could indicate the “glue” is leaking prematurely and preterm delivery is a real possibility.

 

It is also possible to test asymptomatic women at high-risk for preterm labour between 18 and 27+6 weeks.¹

In the majority of maternity hospitals (over 130) in the UK.²

 

Patients presenting with signs or symptoms of preterm labour are eligible to receive a Rapid fFN® test.¹

 

These may include:³

  • – Either a slow trickle or a gush of clear or pinkish fluid from the vagina or any increase in vaginal discharge
  • – Backache
  • – Cramps like strong period pains
  • – A frequent need to urinate
  • – A feeling of pressure in the pelvis
  • – Nausea, vomiting or diarrhoea.

There are studies to support the use of fFN testing in twins.

 

Asymptomatic patients at high risk for preterm birth can also receive a Rapid fFN® test as per the Saving Babies’ Lives Care Bundle, Version 2, Element 5.

Rapid fFN® Testing is CE Marked and licensed for use between 22 and 35+6 weeks in symptomatic women and between 18 and 27+6 weeks in asymptomatic high-risk women.¹

To determine a woman’s risk of preterm delivery in the next 7-14 days1.

 

The test result can also give an indication of the woman’s risk of delivery up to 37 weeks utilising the QUiPP App* (a third party clinical decision-making tool that may help predict spontaneous preterm birth).5

 

Results can be useful when trying to determine whether to admit or transfer her and when to administer interventions such as antenatal corticosteroids, tocolysis and Magnesium Sulphate.

The specimen must be collected prior to other vaginal exams, without gels or lubricants.

  • – During speculum exam, lightly rotate swab across posterior fornix of vagina for 10 seconds to absorb cervicovaginal secretions.
  • – Remove swab and immerse polyester tip in buffer; break shaft at score even with top of tube.
  • – Align the shaft with hole inside the tube cap and push down tightly over shaft, sealing tube.

It is important to note that the Specimen Collection Kit for the Rapid fFN® Test is at no additional cost.

 

Therefore, if you are unsure prior to vaginal examination or additional tests whether any of the following apply, you can take your specimen and subsequently discard it if not required.

 

Contraindications;

  • – Cervical dilation more than 3cm
  • – Rupture of amniotic membranes
  • – Cervical cerclage
  • – Placenta previa
  • – Moderate or gross vaginal bleeding*

 

Precautions;

  • – Specimen contaminated with blood
  • – Sexual intercourse within the previous 24 hours

 

* Moderate or gross bleeding is an independent risk factor for preterm delivery and may be associated with other severe obstetrical or medical problems.

 

Presence of blood or semen in a Rapid fFN® Test sample can sometimes lead to a falsely elevated result, however results under the specified threshold for treatment at your facility can still be considered valid in either of these situations.

Yes, semen in a Rapid fFN® Test sample can sometimes lead to a falsely elevated result, however results under the specified threshold for treatment at your facility can still be considered valid in this situation.

Yes, blood in a Rapid fFN® Test sample can sometimes lead to a falsely elevated result, however results under the specified threshold for treatment at your facility can still be considered valid in this situation.

 

It is important to note however that moderate or gross vaginal bleeding is both a contraindication and is an independent risk factor for preterm delivery and may be associated with other severe obstetrical or medical problems.

Please refer to your hospital’s individual protocol regarding how to interpret your Rapid fFN® Test result as this may vary dependent on whether you are using qualitative fFN, quantitative fFN or the QUiPP App* (a third party clinical decision-making tool that may help predict spontaneous preterm birth).

If you are utilising quantitative fFN, the vast majority of patients, approximately 90%, will receive a low result allowing you to focus on the 10% that really are at the highest risk of preterm delivery¹ .

Once the specimen has been collected, it takes approximately 10 minutes for the PeriLynx Analyser to produce a quantitative fFN test result. ⁴

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. ⁴

The Rapid fFN® Test is on the NHS Supply Chain New Pathology & POCT Framework in the UK. Please feel free to contact us to discuss pricing further.

 

Please note that the Specimen Collection Kits are at no additional cost when purchasing our 10Q Cassettes. This is to allow you to take a patient sample prior to vaginal examination and additional tests then discard if not required.

* 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 https://quipp.org/ and https://www.bapm.org/pages/187-quipp-app-toolkit.

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