Home
HelpTest Code FFN Fetal Fibronectin
Additional Codes
|
Cerner |
NextGen |
|
Fetal Fibronectin |
Fetal Fibronectin |
Useful For/ Methodology
- Detection of fFN in cervicovaginal secretions is associated with preterm delivery in symptomatic pregnant women between 24 weeks and 34 weeks, 6 days gestation and in asymptomatic pregnant women 22 weeks to 30 weeks, 6 days gestation.
- The Rapid fFN assay is a device 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 vaginal 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 gestation and 34 weeks, 6 days gestation.
- The device is further indicated for use in conjunction with other clinical information as an aid in assessing the risk of preterm delivery in women who are less than or equal to 34 weeks, 6 days gestation 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 assay is a qualitative test for the detection of fFN.
Patient Preparation
Test results are difficult to interpret if the specimen contains semen or if the specimen was collected less than 24 hours after coitus. Studies suggest that sperm (or semen) may contain a sufficient concentration of fFN to result in a positive fFN test result. However, even when a patient reports having had intercourse in the previous 24 hours, a negative fFN test result is valid.
Collection Instructions
Specimen Requirements
|
Container |
Rapid FFN Specimen Collection Kit |
|
Stability |
Specimens that are not tested within 8 hours of collection must be stored refrigerated at 2°C to 8°C and assayed within 3 days of collection to avoid degradation of fetal fibronectin. |
|
Rejection Criteria |
|
Result Reporting and Reference Values
|
Reference Range |
Resulted as Negative, Positive, or Invalid |
|
Critical Ranges |
Positive |
Reflex Testing
None
Limitations
- The Rapid fFN result should not be interpreted as absolute evidence for the presence or absence of a process that will result in delivery in less than or equal to 7 or 14 days from specimen collection in symptomatic women or delivery in less than or equal to 34 weeks, 6 days in asymptomatic women evaluated between 22 weeks, 0 days and 30 weeks, 6 days of gestation. A positive Rapid fFN result may be observed for patients who have experienced cervical disruption caused by, but not limited to, events such as sexual intercourse, digital cervical examination, or vaginal probe ultrasound. The Rapid fFN result should always be used in conjunction with information available from the clinical evaluation of the patient and other diagnostic procedures such as cervical examination, cervical microbiological culture, assessment of uterine activity, and evaluation of other risk factors.
- The assay has been optimized with specimens taken from the posterior fornix of the vagina or the ectocervical region of the external cervical os. Samples from other locations should not be used.
- Assay interference from the following components has not been ruled out: --douches, white blood cells, red blood cells, bacteria and bilirubin.
- The presence of infections has not been ruled out as a confounding factor to risk of preterm delivery.
- Manipulation of the cervix may lead to false positive results. Specimens should be obtained prior to digital examination or manipulation of the cervix.
- Care must be taken not to contaminate the swab or cervicovaginal secretions with lubricants, soaps, or disinfectants (e.g., K-Y Jelly lubricant, Betadine disinfectant, Monistat cream). These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of the Rapid fFN assay.
- Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested for fFN.