The Adeza Specimen Collection Kit is the only acceptable specimen collection system which can be used to collect specimens for this assay.
Collection from Symptomatic Women: The specimen should be obtained from the posterior fornix of the vagina.
Collection from Asymptomatic Women: The specimen can be obtained from either the posterior fornix of the vagina or the ectocervical region of the external cervical os.
1. During a sterile speculum exam, insert the Dacron swab (provided with the Specimen Collection Kit) into the vagina as instructed above and lightly rotate swab for approximately 10 seconds to absorb the cervicovaginal secretions.
2. Remove the swab from the vagina or cervical os and place it into the tube of buffer provided with the Specimen Collection Kit.
3. Break the shaft (at the score) even with the top of the tube.
4. Align the shaft with the hole inside the tube cap and push down tightly over the shaft, sealing the tube.
WARNING: The shaft must be aligned to avoid leakage.
5. Label the Specimen container with the Patients name, ID number, Date and Time of collection, and Physician.
6. Store the tube in a refrigerator (2-8C) until transport to the lab.
Obtain the specimen prior to Digital Cervical Examination or Vaginal Probe Ultrasound Exam.
Do not contaminate the swab or cervicovaginal secretions with lubricants, soaps, or disinfectants (e.g., K-Y Jelly, Betadine, hexachlorophene).
Specimens should be collected prior to collection of culture specimens.
Specimens should not be tested if the patient has had sexual intercourse within 24 hours prior to the sampling time.
Specimens should not be obtained from patients with suspected or known placental abruption or placenta previa.
Results should be interpreted with caution when a specimen is obtained from a patient with unconfirmed gestational age.
The fFN Immunoassay is not intended for use in the management of patients with moderate or gross vaginal bleeding.
Rupture of membranes should be ruled out prior to performance of the fFN Enzyme Immunoassay since fFN is found in both amniotic fluid and the fetal membranes.
The fFN Enzyme Immunoassay is not intended for use in patients with cancers of the reproductive tract.
Cotton swabs absorb the fetal fibronectin and are not acceptable for this assay.