[Product Name]

Generic name: Fetal Fibronectin (fFN) Detection Kit (Immunochromatography)

[Packaging Size]

5 tests/kit, 20 tests/kit

[Intended Use]

This kit is used for the qualitative detection of Fetal Fibronectin (fFN) in human cervical vaginal secretions in vitro.
Preterm birth refers to a disease characterized by the interruption of pregnancy after 28 to 37 gestational weeks. Preterm birth is the leading cause of death and disability in most non-hereditary perinatal infants. Symptoms of preterm birth include uterine contractions, changes in vaginal discharge, vaginal bleeding, back pain, abdominal discomfort, a squeezing sensation in the pelvis and cramps. The clinical diagnostic methods for determining preterm birth include detection of uterine contraction activity and digital cervical examinations that can estimate cervical indicators.

As an isoform of fibronectin, Fetal Fibronectin (fFN) is a complex glycoprotein with a molecular weight of about 500KD. For pregnant women with signs and symptoms of preterm birth, if fFN ≥ 50 ng/mL between 0 day of 24 weeks and 6 days of 34 weeks, the risk of preterm birth increases within 7 days or 14 days (from the date of specimen testing from cervical vaginal secretions). For pregnant women without signs and symptoms of preterm birth, if fFN is elevated between 0 day of 22 weeks and 6 days of 30 weeks, there will be an increased risk of preterm birth within 6 days of 34 weeks.

[Storage Conditions and Shelf-life]

Storage Conditions: 4-30°C.
Shelf-life: 12 months
See label for production and expiry dates.
The test cassette should be used within 60 minutes after being taken out of the aluminum foil bag.