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Test Code FFN FETAL FIBRONECTIN

Important Note

 Fetal fibronectin should not be used in the following cases:

  1. Placenta previa or abruption
  2. Moderate or gross vaginal bleeding
  3. Ruptured membranes
  4. Advanced cervical dilation
  5. Sexual intercourse in preceding 24 hours (20%-50% chance of false-positive).

Manipulation of cervix prior to specimen collection may cause a false-positive result.

 

Specimen Stability:

Transport specimen at 2° C to 25°C, or frozen.

Specimen not tested within eight (8) hours of collection must be stored to avoid degradation of the analyte.

  1. Refrigerate specimen at 2° to 8° C if assayed withing 3 days (72) hours fo collection.
  2. Freeze specimen if assayed within 3 months of collection

Methodology

Immunochromatographic Assay

 

Useful as an aid in assessing the risk of preterm delivery in pregnant women sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation.

Specimen Requirements

Obtain cervicovaginal secretions PRIOR TO digital cervix examination using Rapid fFN Specimen Collection Kit.

 

 

Symptomatic Women

Container/Tube: Rapid fFN (Rapid Fetal Fibronectin) Specimen Collection Kit

Specimen Volume: Dacron® swab

Collection Instructions:

  1. During a sterile speculum examination, insert Dacron® swab into vagina and lightly rotate across posterior fornix for approximately 10 seconds to absorb cervicovaginal secretions.
  2. Carefully remove swab from vagina and place into tube of buffer provided with Collection Kit.
  3. Break shaft (at score) even with top of tube. Align shaft with hole inside tube cap and push down tightly over shaft, sealing tube.
  4. Label tube with patient’s legal name, date and actual time of collection, and type of specimen.

 

Asymptomatic Women

Container/Tube: Rapid fFN Specimen Collection Kit

Specimen Volume: Dacron® swab

Collection Instructions:

  1. During a sterile speculum examination, insert Dacron® swab into vagina and lightly rotate across posterior fornix or around ectocervical region of external cervical os for approximately 10 seconds to absorb cervicovaginal secretions.
  2. Carefully remove swab from vaginal or cervical os and place into tube of buffer provided with Collection Kit.
  3. Break shaft (at score) even with top of tube. Align shaft with hole inside tube cap and push down tightly over shaft, sealing tube.
  4. Label tube with patient’s legal name, date and actual time of collection, and type of specimen.

 

 

Specimen Rejection

Specimen rejection will occur:

  1. Storage and Transportation temperature and time are incorrect
  2. Specimen exposed to temperatures >25° C

 

Specimen Retention Time

48 hours

Day(s) Test Set Up

Monday through Sunday

Maximum Laboratory Time

24 hours

Specimen Stability

Transport specimen at 2° C to 25°C, or frozen.

 

Specimen not tested within eight (8) hours of collection must be stored to avoid degradation of the analyte.

  1. Refrigerate specimen at 2° to 8° C if assayed withing 3 days (72) hours fo collection.
  2. Freeze specimen if assayed within 3 months of collection

   Specimen cannot be exposed to temperatures above 25° C (77° F)

 

 

Specimen Type Temperature Time
Swab Ambient < 8 hrs.
  Refrigerate 8 to 72 hrs.
  Frozen  to 3 months

 

Reference Values

Negative (in pregnant women sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation)

Performing Laboratory

Logan Health Medical Center Laboratory

Test Classification and CPT Coding

82731

Special Instructions

MEDICAL PERSONNEL DETAILED INSTRUCTIONS