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Test Code LAB287 Fetal Fibronectin (fFN) Assay

Useful For

  • Predicting preterm delivery in patients with other signs and symptoms of preterm labor
  • Screening high risk women for preterm labor

Methodology

Lateral Flow, Solid-Phase Immunochromatographic Assay

Performing Laboratory

Bozeman Health Laboratory Services

Specimen Requirements

Specimen Type: Vaginal secretions

Collection Container/Tube: Swab

Submission Container/Tube: Adeza Biomedical Specimen Collection Kit

Specimen Volume: Adequate amount

Collection Instructions:

1. Do not use lubricants (eg, K-Y Jelly) on speculum.

2. Obtain specimen from posterior fornix of vagina.

3. Insert polyester-tipped swab into vagina and lightly rotated across posterior fornix for approximately 10 seconds to absorb cervicovaginal secretions.

4. Withdraw swab carefully. Avoid contact with vaginal mucosa.

5. Insert swab into tube of buffer provided.

6. Break shaft (at score-line) even with top of tube. Align shaft with hole inside tube cap, push down tightly over shaft, sealing tube.

7. Label tube with patient’s name (first and last), date and actual time of collection, and type of specimen.

Additional Information:

1. Pelvic examination or sexual intercourse within the previous 24 hours prior to specimen collection may produce a biological false-positive result.

2. Specimen that is very mucoid or grossly-bloody may yield unreliable results.

Specimen Transport Temperature

Ambient

Specimen Stability

 

Specimen Type Temperature Time
Adeza swab kit Ambient 8 hours
  Refrigerated 3 days
  Frozen 3 months

Note: Specimen may be frozen and thawed only once.

 

Reference Values

Negative fFN has a 99% predictive value that patients with signs and symptoms of early labor will NOT deliver in the next 14 days.
Positive fFN has a 12% to 17% predictive value that delivery will occur in 7 to 14 days.

When fFN is used to screen women at high risk for preterm labor at 22 to 31 weeks gestation, a negative result has a 96% predictive value for no preterm labor within the next 4 weeks. A positive result has a 13% to 31% predictive value for delivery within the next 4 weeks.

Day(s) Test Set Up

Monday through Sunday

Test Classification and CPT Coding

82731