fFN Rapid Test Cassette

A qualitative test device for the estimation of the risk for premature birth

The fFN Rapid Test Cassette (vaginal secretion) is a visually interpreted, qualitative immunochromatographic test device for the detection of fFN in cervicovaginal secretions to be used as an aid to assess the risk of pre-term delivery during pregnancy. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.

Special features

  • Detection of fetal fibronectin in vaginal secretion
  • Can be used without speculum1
  • Results in 10 minutes
  • Complete kit with ready to use components
  • Simple and easy handing procedure

Applications

  • Estimate risk of premature birth from week 22 – 35.2
  • Negative test result indicates a very low probability of labor within 7 days
  • The fFN test contributes to a better diagnosis and better subsequent care of the pregnant woman and her unborn child
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Product code: FFF-502 (casette 25 tests)

Introduction

Fetal fibronectin (fFN), an isoform of fibronectin, is naturally elevated in cervicovaginal secretions during the first 24 weeks of pregnancy, but is diminished between 24 and 34 weeks in normal pregnancies. Detection of fFN in cervicovaginal secretions between 24 and 34 completed weeks gestation is reported to be associated with preterm delivery in symptomatic3,4 and asymptomatic pregnant women5,6.

Principle of the fFN Rapid Test Cassette

The fFN Rapid Test Cassette is a visually interpreted, qualitative immunochromatographic test device for the detection of fFN in cervicovaginal secretions, intended as an aid to assess the risk of pre-term delivery during pregnancy. During the test, the specimen is allowed to react with colored anti-fFN antibodies. If fFN is presence in the sample above detectable limits, a colored band will form at the test region of the membrane. Presence of a colored band indicates a positive result, while the absence of a band indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. Presence of this band indicates that proper volume of specimen has been added and membrane wicking has occurred.

References

1. Stafford IP, et al. A comparison of speculum and nonspeculum collection of cervicovaginal specimens for fetal fibronectin testing. Am J Obstet Gynecol (2008) 199(2):131. e1–131.e4

2. Abdelazim et al. Fetal fibronectin (Quick Check fFN test) versus placental alpha microglobulin1 (AmniSure test) for detection of premature rupture of fetal membranes. Arch Gynecol Obstet (2014) 290:457–464

3. Lockwood CJ, et al. Fetal fibronectin in cervical and vaginal secretions as predictor of preterm delivery. New Engl J Med (1991) 325:669-74.

4. Bartnicki J, et al. Fetal fibronectin in vafinal specimens predicts perterm delivery and very low birthweight infants. Am K Obstet Gynecol (1996) 174:971-4.

5. Lockwood CJ, et al. The presence of cervical and vaginal fetal fibronectin predicts preterm delivery in an inner-city obstetric population. Am J Obstet Gynecol (1993) 169:798-804.

6. Morrison JC, et al. Prediction of spontaneous preterm birth by fetal fibronectin and uterine activity. Obstet Gynecol (1996) 87:649-55.

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