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Epic Code LAB287 Fetal Fibronectin (fFN)

Important Note

Specimen must be collected in a special collection kit.

The fetal fibronectin specimen is considered a precious fluid. Follow procedure for handling precious fluids.

Test Name Alias

Fetal Fibronectin | 4075

Interface Order Alias

10379

Specimen Requirements

The Hologic Specimen Collection kit is the only acceptable specimen collection system that can be used to collect specimens for this assay.


Specimen Type: Vaginal Swab
Container/Tube: Hologic Specimen Collection Kit (Rapid fFN)
Minimum volume: 250 µL
Collection Instructions: Follow directions in collection kit for important detailed collection instructions and restrictions.

 

1. During a speculum examination, prior to any examination or manipulation of the cervix or the vaginal tract, lightly rotate the sterile swab across the posterior fornix of the vagina for approximately 10 seconds to absorb cervicovaginal secretions. Subsequent attempts to saturate the swab may invalidate the test.

2. Remove swab and immerse tip in buffer. Break the shaft (at the score) even with the top of the tube.

3. 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.

4. Write the patient’s name and other identifying information required on the specimen transport tube label.

5. Hand deliver the specimen to the laboratory.Transport specimens at 2 to 25°C, or frozen.

6. Specimens not tested within eight (8) hours of collection must be stored refrigerated at 2 to 8°C and assayed within three (3) days of collection, or frozen and assayed within three (3) months to avoid degradation of the analyte. Do not expose to temperatures above 25°C.

Specimen Transport Temperature

Refrigerate

Special Instructions

Indication: 24 – 35 weeks gestation with suspicion of preterm labor. 22 – 30 weeks gestation with suspicion of high risk delivery.

 

Specimen not collected correctly will give inaccurate results. Unacceptable specimens: Bloody specimens. Collected in or by any sample device other than the Hologic Specimen Collection Kit. Insufficient volume. Unlabeled. Refrigerated specimens received greater than 3 days after the sampling date. Specimens received at temperatures greater than 25oC.

 

Specimen Stability

Ambient: 8 hours

Refrigerate: 72 hours

Frozen: 3 months (thaw only once)

Laboratory Retention: 48 hours

Test Frequency

Available 24 hours, usual TAT 1 day.

Reference Range

Reported as Negative (normal) or Positive (abnormal)

The test is performed using the Hologic Rapid fFN assay.  The assay is designed for cervicovaginal secretions from symptomatic patients at gestational ages between 24 weeks 0 days and 34 weeks 6 days.  A negative result indicates a <5% likelihood of delivery within 14 days.  A positive result indicates an increased risk of delivery BUT NOT NECESSARILY imminent preterm delivery.  A positive test warrants additional clinical decision making by obstetric staff based on patient presentation and history.  Use of the test in asymptomatic patients has not yet been fully validated in the literature.

Performing Department

CHEMISTRY

Performing Department Laboratory Location

Spectrum Health Regional Laboratory, Grand Rapids, MI
Spectrum Health Big Rapids Laboratory, Big Rapids, MI
Spectrum Health Gerber Laboratory, Fremont, MI

Spectrum Health Ludington Laboratory, Ludington, MI

Spectrum Health Pennock Laboratory, Hastings, MI
Spectrum Health United Laboratory, Greenville, MI
Spectrum Health Zeeland Laboratory, Zeeland, MI

Methodology

Lateral flow, solid phase Immunochromatographic assay.

CPT

82731-LAB-FETAL FIBRONECTIN

CDM Code

4054075

Epic Test ID

1230100687

LOINC

Fetal Fibronectin: 20404-0

Beaker LOINC

FETAL FIBRONECTIN: 20404-0

Mayo Access Code

SHO4075

Reviewed Date

3/5/2020

Beaker Names

Beaker Procedure Name: FETAL FIBRONECTIN
Beaker Display Name: Fetal Fibronectin (fFN)
BEAKER TEST NAME: FETAL FIBRONECTIN
BEAKER TEST REPORT NAME: Fetal Fibronectin

Beaker Synonyms

No synonym on file

Beaker Location, Container and Temperature

BW URINES: SWAB A (Preferred)-Refrigerated
BR CHEMISTRY: SWAB A (Preferred)-Refrigerated
GM CHEMISTRY: SWAB A (Preferred)-Refrigerated
LH CHEMISTRY: SWAB A (Preferred)-Refrigerated
UN CHEMISTRY: SWAB A (Preferred)-Refrigerated
ZH CHEMISTRY: SWAB A (Preferred)-Refrigerated