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 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. Samples obtained from other locations should not be used

The safety and effectiveness of using a cutoff other than that provided by the Rapid fFN Cassette Calibration Code has not been established.
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
Assay interference from semen has not been ruled out. Specimens should not be collected less than 24 hours after intercourse. However, even when patient reports having had intercourse in the pevious 24 hours, a negative fetal fibronectin test result is valid.

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 applicator or cervicovaginal secretions with lubricants, soaps, disinfectants or creams (e.g., K-Y Jelly lubricant, Betadine disinfectant, Monistat cream, hexachlorophene). These substances may interfere with absorption of the specimen by the applicator or with the antibody-antigen reaction of the Rapid fFN test. Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding, should not be tested for fFN

This test will detect fetal fibronectin in cervicovaginal secretions in pregnant women at risk preterm delivery.  Interferences from: semen, douches, blood cells, bacteria or bilirubin have not been ruled out.  Lubricants, soaps, disinfectants or creams may interfere with this test.