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Test Code FFN Fetal Fibronectin

Additional Codes

EPIC LAB4089

Clinical Significance

The rapid fFN cassette for use in the TLiIQ system is an in vitro diagnostic device 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 of gestation.

 

The rapid fFN test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in < 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

 

The rapid fFN test represents a significant and critically needed improvement in the ability to manage preterm labor that may result in preterm delivery.

 

Source: Rapid Fetal Fibronectin Enzyme Immunoassay and Rapid fFNTM for the TLiIQ System IFU, Hologic, AW-04196-002 Rev. 002 12/2020

Methodology

Lateral flow, solid-phase immuno-chromatographic assay (Rapid fFn TLIQ)

Sample Type

Collection Kit Collection Site
Hologic Specimen Collection Kit Posterior fornix (preferred)
Ectocervical region of the external os

 

Specimen Minimum Volume

200 uL of the buffer from the collection kit.

Specimen Stability

Temperature Time
Ambient (18-25°C) 8 hours
Refrigerated (2-8°C) (store) 72 hours
Frozen (<-20°C) 3 months*

Transport to lab at 2-25°C. Do not exceed 25°C.

*Thaw only once.

Reference Ranges

Negative

Rejection Criteria

  • Contamination of swab with lubricants, soaps, disinfectants or creams.
  • Moderate or gross blood may give false result, but if negative the result is still valid.
  • The presence of amniotic fluid will cause a positive result, so the rupture of membranes should be ruled out prior to collection.
  • The test is only valid on pregnant women with a gestation between 24 weeks, 0 days and 34 weeks, 6 days.
  • There should only be minimal dilation < 3 cm.

Contraindications

The rapid fFN test should not be used for symptomatic women with one or more of the following conditions:

  • Advanced cervical dilatation (>2 cm)
  • Rupture of amniotic membranes
  • Cervical cerclage
  • Moderate or gross vaginal bleeding

Delivery typically occurs imminently when the cervix is dilated more than 3 cm or if the amniotic membranes are ruptured. Additional diagnostic testing is usually not necessary to confirm risk for women with advanced cervical dilatation or rupture of amniotic membranes. Moderate or gross vaginal bleeding is an independent risk factor for preterm delivery and may be associated with other severe obstetrical or medical problems. Clinical attention should be focused on identification of the origin of the bleeding rather than immediate assessment of delivery risk. At this time, information is insufficient regarding the association of vaginal fetal fibronectin expression to delivery for women with cervial cerclage.

 

The rapid fFN test should not be used for asymptomatic women with one or more of the following conditions:

  • Multiple gestations
  • Cervical cerclage
  • Placenta previa (partial or complete)
  • sexual intercourse in the preceding 24 hours

At this time, information is insufficient regarding the association of cervicovaginal fetal fibronectin expression to delivery for asymptomatic women with HIV/AIDS, multiple gestations, or cervical cerclage.

Availability

Performed STAT
24/7 Yes

 

Performing Laboratory

MultiCare Yakima Memorial Hospital Laboratory

Lab Department

Chemistry

CPT Code

82731

LOINC

48039-2 Fibronectin.fetal QI (Specimen)