Fetal Fibronectin- Rapid

LAB287

FFN

Qualitative detection of fetal fibronectin

Collect cervicovaginal secretions in Hologic Specimen Collection Kit
Refrigerate within 8 hours

Transport specimens at 2° to 25°C.

Specimens not tested within eight hours of collection must be stored refrigerated at 2° to 8°C and assayed within three days of collection.

1.  Do not use kit if swab package integrity is compromised or if specimen transport tubes have leaked.
2. Specimens not tested within eight hours of collection must be stored refrigerated at 2° to 8°C and assayed within three days of collection.
3. Fetal Fibronectin tests are not intended for use in women with moderate or gross vaginal bleeding. The presence of vaginal bleeding may contribute to difficulty in interpreting the fetal fibronectin test result. Testing a bloody sample may lead to false positive results. However, if the test is negative, it should be considered a valid result. If upon visual examination you are concerned about the presence of moderate or gross vaginal blood, we recommend collecting a sample following cessation of active vaginal bleeding.

Daily/STAT

Routine 8 hours Stat 3 hours

The Fetal Fibronectin Enzyme Immunoassay and Rapid FFN for the TLiIQSystem are devices used as an aid in assessing 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 dilatation (<3 cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation.
Patient specimens having a signal intensity greater than or equal to the signal intensity specified by the reference calibration value (0.05ug/mL FFN) will be displayed as “Positive” on the TLiIQ Analyzer.
Patient specimens having a signal intensity less than or equal to the signal intensity specified by the reference calibration value (0.05ug/mL FFN) will be displayed as “Negative” on the TLiIQ Analyzer.