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HelpTest Code LAB287 Fetal Fibronectin
Intended Use
The Rapid fFN cassette for use in the Hologic TLiIQ System is an in vitro diagnostic device for the detection of fetal fibronectin (fFN) in cervicovaginal secretions to be used as an aid to rapidly assess the risk of preterm delivery in ≤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 dilation (<3 cm), sampled between 24 weeks, 0 days, and 34 weeks, 6 days gestation.
Methodology
Lateral Flow, Solid-Phase Immunochromatographic Assay
Performing Laboratory
RCH
Specimen Requirements
Asymptomatic Women
1. Specimen should be obtained from either posterior fornix of vagina or ectocervical region of external cervical os during a sterile speculum examination. Dacron® swab provided in Specimen Collection Kit should be inserted into vagina and lightly rotated across posterior fornix or around ectocervical region of external cervical os for approximately 10 seconds to absorb cervicovaginal secretions.
2. Once specimen is obtained, carefully remove swab from vagina or cervical os and immerse Dacron® tip in tube of buffer provided with Specimen Collection Kit.
3. Break shaft (at score line) even with top of tube. Align shaft with hole inside tube cap and push down tightly over shaft, sealing tube.
4. Write patient’s name and any other identifying information required on tube label.
Symptomatic Women
1. Specimen should be obtained from posterior fornix of vagina during a sterile speculum examination. Dacron® swab provided in Specimen Collection Kit should be inserted into vagina and lightly rotated across posterior fornix for approximately 10 seconds to absorb cervicovaginal secretions.
2. Once specimen is obtained, carefully remove swab from vagina or cervical os and immerse Dacron® tip in tube of buffer provided with Specimen Collection Kit.
3. Break shaft (at score line) even with top of tube. Align shaft with hole inside tube cap and push down tightly over shaft, sealing tube.
4. Write patient’s name and any other identifying information required on tube label.
Specimen Stability
Ambient (Preferred): Up to 8 hours
Refrigerated: >8 hours
Day(s) Test Set Up
Monday through Sunday
Test Classification and CPT Coding
82731