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Epic Test Code LAB3772 Fetal Fibronection (Rapid fFN)

Performing Location(s)

MIB

Specimen Type

Vaginal swab immersed in buffer

Preferred Container

Must use Cytyc Specimen Collection Kit

Storage Requirements

Specimens that are not tested within eight (8) hours of collection must be stored refrigerated at 2-8 C and assayed within three (3) days of collection, or frozen at 0 to -20 C and assayed within three (3) months. Store appropriately and avoid extreme temperatures.
Discard specimens into a biohazard receptacle after testing is complete.

Minimum Volume

250 uL

Transportation Needs

Room Temperature within 8 hours

2°- 8°C within 3 days

0°-(-20°) C within 3 months

Causes for Rejection

Mislabeled or unlabeled specimen

Specimens collected in or by any sample device other than the Cytyc Specimen Collection Kit

Specimens with insufficient volume for testing.

Specimens which were not frozen and received >3 days after the sampling date.
Specimens received at temperatures > 25° C
Specimens subjected to more than one freeze-thaw cycle

Bloody specimen

> 8 hours at Room Temperature

> 3 days Refrigerated

Days of Analysis

All

Additional Information

Patient Preparation:

Avoid sexual intercourse for 24 hours prior to collection

Avoid use of lubricants, soaps, disinfectants, or creams

 

Specimen Collection:

1. Obtain the specimen using the Cytyc Specimen Collection Kit. The specimen should be obtained from the posterior fornix of the vagina during a speculum examination. The polyester-tipped applicator provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervicovaginal secretions.

2. Once the specimen is obtained, carefully remove the applicator from the vagina and immerse the tip in the tube of buffer provided with the Specimen Collection Kit.
3. Break the shaft (at the score) even with the top of the tube. Align the shaft with the hole inside the tube cap and push down tightly over the shaft, sealing the tube.
4. Label the tube with the patient’s name, medical record, time and date of collection, and initials of person collecting the specimen

Available STAT

Yes

Reference Values

Population Units Reference Range
All populations none Negative

 

Limitations

The Rapid fFN result should not be interpreted as absolute evidence for the presence or absence of a process that will result in delivery in (less than or equal to) 7 or 14 days from specimen collection in symptomatic women or delivery in less than or equal to 34 weeks, 6 days in asymptomatic women evaluated between 22 weeks, 0 days and 30 weeks, 6 days of gestation. A positive fFN result may be observed for patients who have experienced cervical disruption caused by, but not limited to, events such as sexual intercourse, digital cervical examination, or vaginal probe ultrasound. The Rapid fFN result should always be used in conjunction with information available from the clinical evaluation of the patient and other diagnostic procedures such as cervical examination, cervical microbiological culture, assessment of uterine activity, and evaluation of other risk factors

 

The assay has been optimized with specimens taken from the posterior fornix of the vagina. Samples obtained from other locations should not be used

The safety and effectiveness of using a cutoff other than that provided by the Rapid fFN Cassette Calibration Code has not been established.
Assay interference from the following components has not been ruled out: douches, white blood cells, red blood cells, bacteria, and bilirubin.

 

The presence of infections has not been ruled out as a confounding factor to risk of preterm delivery
Assay interference from semen has not been ruled out. Specimens should not be collected less than 24 hours after intercourse. However, even when patient reports having had intercourse in the pevious 24 hours, a negative fetal fibronectin test result is valid.

 

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

Care must be taken not to contaminate the applicator or cervicovaginal secretions with lubricants, soaps, disinfectants or creams (e.g., K-Y Jelly lubricant, Betadine disinfectant, Monistat cream, hexachlorophene). These substances may interfere with absorption of the specimen by the applicator or with the antibody-antigen reaction of the Rapid fFN test. Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding, should not be tested for fFN

 

This test will detect fetal fibronectin in cervicovaginal secretions in pregnant women at risk preterm delivery.  Interferences from: semen, douches, blood cells, bacteria or bilirubin have not been ruled out.  Lubricants, soaps, disinfectants or creams may interfere with this test.

Methodology

Lateral flow, solid-phase immunochromatographic assay

CPT Code

82731

Last Updated

30-Apr-19