Fetal Fibronectin

FEFIB

FFN

FLUID(FLD) Adeza Collection Kit

The Adeza Biomedical specimen collection kit is the only acceptable specimen collection system that can be used to collect specimens for this assay.  The sample should be collected by a physician, Certified Nurse Midwife, or a labor and delivery RN.
 
Fetal Fibronectin samples will be obtained on all patients between 24 - 36 weeks gestation who present with signs/symptoms of preterm labor, prior to performing a vaginal examination.

• Collection from symptomatic Women: The specimen should be obtained from the posterior fornix of the vagina during a sterile speculum examination.
• Collection from asymptomatic Women: The specimen can be obtained from either the posterior fornix of the vagina or the ectocervical region of the external cervical OS during a sterile speculum examination.

Once the specimen is obtained, the swab is placed into the tube of buffer provided with the specimen collection kit.
 
Specimen Collection Guidelines:

• Specimens should be obtained prior to Digital Cervical Examination of Vaginal Probe Ultrasound Examination as manipulation of cervix may cause release of fFN.
• Care must be taken not to contaminate the swab or cervicovaginal secretions with lubricants, soaps, disinfectants, or creams. Lubricants or creams may physically interfere with absorption of the specimen onto the swab. Soaps or disinfectants may interfere with the antibody-antigen reaction.
• Collection of vaginal specimens for culture frequently requires aggressive collection techniques which may abrade the cervical or vaginal mucosa. Since cellular debris may potentially interfere with sample preparation, specimens should be collected prior to collection of culture specimens.
• Collecting a specimens from patients meeting the following criteria is NOT recommended:
  • Patients who had sexual intercourse within 24 hours or have used vaginal cream or gel within the past 24 hours, prior to the sampling time should not be tested.
  • Specimens should not be obtained from patients with suspected or known placental abruption or placenta previa.
  • Patient has advanced cervical dilation (3 cm or greater).
  • Patient has open cervical and/or vaginal lesions present.
  • Patient has rupture of membranes, bulging membranes or moderate or gross vaginal bleeding.

Transport specimens at 2°C to 25°C. Specimens that are not tested within 8 hours of collection must be stored refrigerated at 2 to 8°C and assayed within 3 days of collection to avoid degradation of fetal fibronectin.

• Specimens collected in a sample kit other than Adeza Biomedical specimen collection kit.
• Specimens received >3 days after the sampling date.
• Specimens received at temperatures >25°C.

24x7

Qualitative Test:

• Negative:  Low risk of preterm delivery within next 14 days
• Positive:   Increased risk of delivery within next 14 days.

A rapid test for the detection of fetal fibronectin in Cervicovaginal secretions to be used as an aid to rapidly assess the risk of preterm delivery in <7 or <14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (<3 cm), sampled between 24 weeks, 0 days, and 34 weeks, 6 days gestation.