FETAL FIBRONECTIN - (Fl)

Test Code: FFN

Test performed at:  Westman Lab, Dauphin Regional Health Centre, Thompson General Hospital, The Pas Health Complex
Test Indications: The Rapid Fetal Fibronectin test at 24-35 weeks of gestation is used as an aid in assessing the risk of preterm delivery upto 10 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor with intact amniotic membranes and minimal cervical dilatation (< 3 cm).
Recommendations:  Limitations of fFN testing and required precautions:
1) Specimens should not be collected less than 24 hours after intercourse. However, even when a patient reports having had intercourse in the previous 24 hours, a negative fetal fibronectin test result is valid.
2) Manipulation of the cervix may lead to false positive results. Specimens should be obtained prior to digital examination or manipulation of the cervix.
3) Care must be taken not to contaminate the swab or cervicovaginal secretions with lubricants, soaps, disinfectants, or creams (e.g., K-Y® Jelly lubricant, Betadine® disinfectant, Monistat® cream, hexachlorophene). These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of the Rapid fFN test.
4) Testing should not be performed in patients with multiple gestations (e.g., twins), pre-eclampsia, cervical cerclage or placenta previa (partial or complete) due to false positive results.
Patient Preparation Instructions:  The specimen should be obtained from the posterior fornix of the vagina or ectocervical region of the external cervical or during a sterilized speculum exam.  Collect the specimen first before any other type of cervical exam/procedure. Hologic Rapid fFN® for the TLiIQ® System Specimen Collection Kit provides a swab that is inserted into the vagina and lightly rotated for a minimum of 10 seconds to fully absorb secretions from the area described above.

Hologic Rapid fFN® for the TLiIQ® System Specimen Collection Kit 

_SH Body Fluid Requisition (R250-10-53)

Rapid fetal fibronectin is a qualitative test and results are reported as Positive or Negative.
In women with signs and symptoms of preterm labor, a systematic review of five randomized trials and 15 diagnostic test accuracy studies evaluating cervicovaginal fFN for predicting preterm birth reported the following estimates:
- Delivery upto 10 days of testing – Sensitivity and specificity 76.7 and 82.7 percent, respectively.
- Negative result would indicate delivery will be unlikely within 14 days from testing.

Reference for Reference Values: Uptodate, Preterm labor: Clinical findings, diagnostic evaluation, and initial treatment, accessed on Oct 16, 2020

Upon Request 24 hours per day, 7 days per week.

Sample Stability:

8 hours:	room temperature
3 days:	2-8°C
3 months:	-20°C