Pregnancy test kit FFN-501

fibronectinvaginal secretionsimmunochromatographic

Product overview
The fetal fibronectin (fFN) rapid test (vaginal secretion) is a visually interpreted, qualitative immunochromatographic assay for detecting fFN in vaginal secretions during pregnancy. Designed for use by healthcare professionals as an in vitro diagnostic to aid in assessment of preterm labour risk and diagnosis of rupture of fetal membranes (ROM).

Intended use
For healthcare professional use to detect fetal fibronectin in vaginal secretions to assist clinical assessment of preterm labour risk and in the diagnosis of rupture of fetal membranes. For in vitro diagnostic use only.

How fFN works
Fetal fibronectin is an extracellular matrix protein detectable in vaginal secretions early when the fetal-uterine interface forms and again near term. Detectable levels between gestational weeks 22 and 35 may indicate an increased risk of preterm delivery. fFN results should be interpreted alongside clinical findings such as contractions and cervical changes.

Operating steps

• Bring tests, specimens, buffer and controls to room temperature (15–30°C) before use.
• Remove the test from its sealed pouch and place it on a clean, level surface. Label the test with patient or control identification. Perform the assay within one hour after opening for best results.
• Add the extracted buffer into the sample well. As the assay runs, colored material will migrate across the membrane.
• Wait for the colored band(s) to appear and read the result at 10 minutes. Do not interpret results after 20 minutes.

Additional information
Qualitative immunochromatographic assay (colloidal gold). Available in strip or cassette format. Typical reading time 10–15 minutes. Reported accuracy approximately 99%. For professional use (IVD).

Key product data
Product Name: fFN rapid test (vaginal secretion)
Specimen: Vaginal secretion
Method: Colloidal gold immunochromatographic rapid test (visual qualitative assay)
Form / Dosage Form: In Vitro Diagnostic rapid test strip or cassette
Reading Time: 10–15 minutes (read at 10 minutes; do not interpret after 20 minutes)
Accuracy: Approximately 99%
Format: Strip or cassette
Certification: CE, ISO13485
Shelf Life: 24 months
Package: 20 tests per box

Technical specifications

• Product Name: fFN rapid test (vaginal secretion)
• Specimen Type: Vaginal secretion
• Assay Principle: Immunochromatographic assay (colloidal gold)
• Format: Strip or cassette
• Intended Users: Healthcare professionals (in vitro diagnostic)
• Reading Time: 10–15 minutes (do not interpret after 20 minutes)
• Accuracy: Approximately 99%
• Certifications: CE, ISO13485
• Shelf Life: 24 months
• Packaging: 20 tests per box