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Test Code LAB287 FETAL FIBRONECTIN

Additional Codes

CPT Code: 82731

Methodology

Rapid fFN test is to be used as an aid in assessing risk of preterm delivery ≤7 to 14 days from time of cervicovaginal specimen 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 and 34 weeks, 6 days gestation.

Performing Laboratory

Peninsula Regional Medical Center - Chemistry

Specimen Requirements

Specimen must be tested within 8 hours of collection at ambient temperature or 72 hours of collection at refrigerated temperature.

 

Obtain specimen using Hologic Biomedical Specimen Collection Kit prior to digital examination or manipulation of cervix.

Note: Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested for fFN.

 

Asymptomatic Women

1. Obtain specimen from posterior fornix of vagina or ectocervical region of external cervical os during a sterile speculum examination. (Improperly labeled specimen, specimen collected in or by any sample device other than Adeza Biomedical Specimen Collection Kit, specimen with insufficient volume for testing, specimen received ≥72 hours of collection, or specimen received at >25° C.)

2. Do not contaminate specimen with lubricants, soaps, disinfectants, or creams.

3. Dacron swab provided in 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.

4. Once specimen is obtained, carefully remove swab and immerse swab into tube of buffer provided with kit.

5. Break shaft (at score) even with top of tube. Align shaft with hole inside tube cap and push down tightly over shaft, sealing tube.

6. Label tube with patient’s name and hospital number.

7. Forward promptly at ambient temperature, avoiding exposure to extreme temperatures. Refrigerate specimen at 2° C to 8° C if unable to test within 8 hours of collection.

 

Symptomatic Women

1. Obtain specimen from posterior fornix of vagina during a sterile speculum examination. (Improperly labeled specimen, specimen collected in or by any sample device other than Adeza Biomedical Specimen Collection Kit, specimen with insufficient volume for testing, specimen received ≥72 hours of collection, or specimen received at >25° C.)

2. Do not contaminate specimen with lubricants, soaps, disinfectants, or creams.

3. Dacron swab provided in collection kit should be inserted into vagina and lightly rotated across posterior fornix for approximately 10 seconds to absorb cervicovaginal secretions.

4. Once specimen is obtained, carefully remove swab and immerse swab into tube of buffer provided with kit.

5. Break shaft (at score) even with top of tube. Align shaft with hole inside tube cap and push down tightly over shaft, sealing tube.

6. Label tube with patient’s name and hospital number.

7. Forward promptly at ambient temperature, avoiding exposure to extreme temperatures. Refrigerate specimen at 2° C to 8° C if unable to test within 8 hours of collection.

Reference Values

If a patient is between 24 to 35 weeks gestation and has symptoms of premature labor, a negative result indicates a 99.2% probability that patient will not deliver in next 14 days.

A positive result implies a 16.7% probability that patient will deliver within next 14 days.

Note: 1. Assay is optimized with specimen taken from posterior fornix of vagina or ectocervical region of external cervical os. Specimen obtained from other locations should not be used.

2. Assay interference from the following components has not been ruled out: douches, WBCs, RBCs, bacteria, and bilirubin.

3. Infection has not been ruled out as a confounding factor to risk of preterm delivery.

4. Assay interference from semen has not been ruled out. Specimen should not be collected <24 hours after intercourse. However, even when a patient reports having had intercourse in previous 24 hours, a negative fetal fibronectin test result is valid.

5. Manipulation of cervix may lead to false-positive results. Specimen should be obtained prior to digital examination or manipulation of the cervix.