Use to assess risk of preterm delivery in less than or equal to 7-14 days from time of sample collection at 24 weeks 0 days to 34 weeks 6 days gestation when there are signs and symptoms of early preterm labor in women with intact amniotic membranes and minimal cervical dilation (<3 cm). May also aid in the assessment of risk of preterm delivery in less than or equal to 34 weeks gestation when a cervicovaginal specimen is obtained during a routine office visit between 22 weeks 0 days and 30 weeks, 6 days gestation in women with a singleton gestation.
Lateral flow immunoassay
Within 24 hours
New York DOH Approval Status
Collect specimen prior to any activities or procedures that might disrupt the cervix, eg, coitus, digital cervical examination, vaginal ultrasound, collection of culture specimens, or pap smear.
Testing should not be performed if the patient has had sexual intercourse within 24 hours prior to the sampling time because semen present may increase the possibility of a false-positive result. Contamination with lubricants, soaps, or disinfectants may cause invalid test results.
Insert the polyester-tipped swab provided in the specimen collection kit into the vagina and lightly rotate across the posterior fornix for approximately 10 seconds to absorb cervicovaginal secretions. Carefully remove the swab and place into the tube of buffer provided in the kit. Use only one specimen collection device per patient.
Specimens that are not tested within eight hours of collection must be stored, refrigerated, and tested within 72 hours of collection. Avoid extreme temperatures. Transport swab in Fetal Fibronectin Specimen Collection Kit (ARUP supply #32748). Available online through eSupply using ARUP Connect™ or contact Client Services at (800) 522-2787. Required Information: Specimen must be labeled with gestational age and list patient condition as either "symptomatic" or "asymptomatic."
Specimens collected in or by any specimen device other than Fetal Fibronectin Specimen Collection Kit, visible evidence of moderate or gross vaginal bleeding. Specimens from symptomatic patients who are less than 24 weeks or greater than or equal to 35 weeks gestation. Specimens from asymptomatic patients who are less than 22 weeks or greater than or equal to 35 weeks gestation.
Ambient: 8 hours; Refrigerated: 3 days; Frozen: 2 weeks Only one freeze/thaw cycle acceptable.
Among symptomatic women, a positive result obtained between 24 weeks, 0 days and 34 weeks, 6 days indicates increased risk of delivery in less than or equal to 7-14 days from sample collection.
Among asymptomatic women, a positive result between 22 weeks, 0 days and 30 weeks, 6 days indicates increased risk of delivery in less than or equal to 34 weeks, 6 days of gestation.
|Component Test Code*||Component Chart Name||LOINC|
|0082026||fFN Labor Symptoms||57069-7|
|0082027||fFN Gestational Age|