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