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Published on February 02, 2018
SIM
96900
CPT
82731
Synonyms
FFN, Rapid FFN
Specimen Type
Use only Hologic Specimen Collection swabs.
Container
Use only Hologic Specimen Collection kits.
Collection Instructions
1. The specimen should be obtained from the posterior fornix of the vagina during a speculum examination. The polyester-tipped swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervicovaginal secretions. The collection will be performed by the physician. 2. Once the specimen is obtained, carefully remove the swab from the vagina and immerse the swab tip in the tube of buffer provided with the Specimen Collection Kit. 3. 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.
Volume
1 Swab in the Hologic Specimen Collection kit
Additional Information
1. The Rapid FFN test is to be used as an aid in assessing the risk of preterm delivery in less than or equal to 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 dilatation (< 3 cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. 2. The Rapid FFN test is further indicated for use in conjunction with other clinical information as an aid in assessing the risk of preterm delivery in less than or equal to 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.
Patient Preparation
Specimens should not be collected within 24 hours of any type of vaginal exam or intercourse.
Specimen Processing Instructions
Refrigerate swab kit
Transport Requirements
Refrigerate
Specimen Stability
Specimens that are not tested within eight (8) hours of collection must be stored refrigerated at 2 to 8 degrees Celcius and assayed within three (3) days of collection.
Rejection Criteria
1. Specimens collected in or by any sample device other than the Hologic Biomedical Specimen Collection Kit. 2. Specimens with insufficient volume for testing. 3. Specimens received unlabeled. 4. Specimens received > 3 days after the sampling date.
Reference Range
Negative
Critical Value
none
Test Includes
Fetal Fibronectin
Methodology
Lateral flow, Solid-phase Immunochromatographic assay
Testing Frequency
Daily, Monday - Sunday
Reviewed By
Sandy Hammett
Reviewed Date
2-2-18
Supplemental
Reviewed by Sandy Hammett on February 02, 2018
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