FETAL FIBRONECTIN

Message

Chemistry

Test Code

LAB287

Alias/See Also

Fibronectin
FFN
Rapid FFN

CPT Codes
82731

Preferred Specimen

Cervicovaginal specimen – use Hologic Specimen Collection Kit

Minimum Volume

Hologic specimen collection tube contains premeasured buffer solution. Please do not tamper.

Instructions

Only results from the specimens obtained during a speculum examination are valid

During a speculum examination, prior to any examination or manipulation of the cervix or the vaginal tract, lightly rotate the sterile swab across the posterior fornix of the vagina for approximately 10 seconds to absorb cervicovaginal secretions. Subsequent attempts to saturate the swab may invalidate the test.
Remove the Hologic Perinatal Swab (sterile, polyester-tip swab) and immerse tip in buffer. Break the shaft (at the score) even with the top of the tube.
Align the shaft with the hole inside the tube cap and push down tightly over the shaft, sealing the tube. Warning: The shaft must be aligned to avoid leakage.
Label tube with patient’s identifier

Transport Container

Hologic specimen collection kit

Transport Temperature

Transport specimens at 2ºC-25 ºC, or frozen

Specimen Stability

Specimens not tested within eight (8) hours of collection must be stored refrigerated at 2º to 8ºC and assayed within three (3) days of collection, or frozen and assayed within three (3) months to avoid degradation of the analyte. Do not expose to temperatures above 25ºC

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimens obtained in any other manner or other collection device than that was specified

Methodology
Lateral flow, solid-phase immune-chromatographic assay

FDA Status
Approved

Setup Schedule

STAT

Report Available

Within 1 - 2 hours

Limitations

Assay interference from semen has not been ruled out. Specimen should not be collected less than 24 hours after intercourse. However, even when a patient reports having had intercourse in the previous 24 hours, a negative fetal fibronectin test result is valid.
Care must be taken not to contaminate the swab or cervicovaginal secretions with lubricants, soaps, disinfectants or creams (e.g. K-Y Jelly lubricant, Betadine disinfectant, Monitstat cream,hexachlorophene). These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of fetal fibronectin test.
Fetal Fibronectin tests are not intended for use in women with moderate or gross vaginal bleeding. The presence of vaginal bleeding may contribute to difficulty in interpreting the fetal fibronectin test result. Testing a bloody sample may lead to false positive results. However, if the test is negative, it should be considered a valid result. If upon visual examination you are concerned about the presence of moderate or gross vaginal blood, we recommend collecting a sample following cessation of active bleeding.
Assay interference from the following components has not been ruled out: douches, white blood cells, red blood cells, bacteria, and bilirubin.
Rupture of membranes should be ruled out prior to specimen collection since fetal fibronectin is found in both amniotic fluid and fetal membranes.
Fetal Fibronectin tests are not intended for use in patients with cancers of the reproductive tract

Reference Range

Negative

Performing Laboratory
Hoag Newport
Hoag Irvine

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.