The Fetal Fibronectin (fFN) Rapid Test Kit is a membrane-based immunochromatographic fetal fibronectin test for the qualitative detection of fFN in vaginal secretion samples from pregnant women. It is intended for professional use as an aid in the assessment of preterm birth risk.

• Qualitative fFN detection: Detects fetal fibronectin in vaginal secretion specimens.
• Rapid result: Provides a result within 15 minutes.
• Simple procedure: Uses a three-step testing workflow.
• Built-in quality control: Helps ensure reliable test results.
•    Shelf life: 18 months

The limit of detection (LOD): ≦50ng/ml

Positive agreement: 97.25%

Negative agreement: 93.69%

Storage temperature: 4℃-30℃

Transportation temperature: -20℃~45℃

Sample type: Vaginal secretion

The rapid fetal fibronectin test kit is designed for professional prenatal care settings. Applications include:

• Preterm birth risk assessment support: Qualitative fFN testing as one part of the clinical evaluation of pregnant women.
• Vaginal secretion testing: Use of the specified vaginal secretion sample collected according to the product instructions.
• Time-sensitive obstetric workflows: Fifteen-minute testing where a rapid laboratory result can complement other clinical information.
• Result interpretation support: Use of positive or negative fFN findings together with symptoms, gestational information and other assessments.

CE, NMPA