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22625 Fetal Fibronectin

Fetal Fibronectin
Test Code: FFN
Synonyms/Keywords
Fibronectin, Fetal, FFN​
Useful For
The Rapid fFN assay is useful for assessing the risk of pre-term delivery in primarily symptomatic women but also asymptomatic women with a history of pre-term labor symptoms.​
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No​ Cervicovaginal secretions​
Cytyc (formerly Adeza) collection kit containing a polyester tipped applicator and transport vial with buffer
 
Contact laboratory for kit​
 ​
1 swab in buffer​
 ​ ​
Collection Processing Instructions
Only samples collected using the Cytyc kits will be accepted.
 
During a sterile speculum examination, insert the applicator and lightly rotate across the posterior formix or around the ectocervical region of the external cervical os for approximately 10 seconds. Remove the swab and immerse swab tip in buffer. Break the shaft of the swab even with the top of the tube. Align the shaft with the hole inside the tube cap. Seal tube with cap and send to the laboratory as soon as possible.

Specimen should be obtained prior to digital exam or vaginal probe ultrasound as manipulation of the cervix may cause release of fetal fibronectin. Do not contaminate the sample or swab with lubricants (K-Y Jelly), soaps, or disinfectants (eg. Betadine). Patient should not have had sexual intercourse within the 24-hour period prior to sampling (potential for a false positive).​

For more information on Specimen Collection Media/Swab, see Specimen Transport Pictorial.
Acceptable Body Sites
Cervical​
Specimen Stability Information
Specimen Type Temperature Time
Cervicovaginal secretions in Cytyc kits ​ Ambient​ 8 hours​
Cervicovaginal secretions in Cytyc kits​ Refrigerated​ 72 hours​
Cervicovaginal secretions in Cytyc kits​ Frozen​ 3 months​
Rejection Criteria
Samples collected with any other type of collection devices
Moderately or grossly bloody​
Contaminated with lubricants, soaps, or disinfectants​
Interference
Assay interference from the following components has not been ruled out: douches, WBCs, RBCs, bacteria and bilirubin.
 
Care must be taken not to contaminate the swab or cervico-vaginal secretions with lubricants, soaps, or disinfectants (e.g., K-Y® Jelly lubricant, Betadine® disinfectant, Monistat® cream). These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of the Rapid fFN assay.
 
Test results are difficult to interpret if the specimen contains semen or if the specimen was collected less than 24 hours after intercourse.​
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Diagnostic Treatment Center​ ​Monday through Sunday​ ​Less than 2 hours​ ​Solid Phase Immunochromatographic Assay/Hologic Inc
​Eau Claire ​Monday through Sunday ​Less than 2 hours ​Lateral Flow Solid Phase Immunochromatographic Assay/Hologic Inc
​Lakeview Medical Center ​Monday through Sunday​ ​Less than 2 hours​ ​Lateral Flow Solid Phase Immunochromatographic Assay/Hologic Inc
Marshfield​ Monday through Sunday​ Less than 2 hours​ Lateral Flow Solid Phase Immunochromatographic Assay/Hologic Inc
Test Information
If sending from another facility please call Marshfield Labs, 800-222-5835, prior to sending STAT samples. Stat requests will be completed as received. Please supply detailed call-back information, otherwise results will be called next a.m. during routine work hours.​
Reference Range Information
Performing Location Reference Range
All Performing Sites Non-detected (Negative)​
Interpretation
The presence of infections has not been ruled out as a confounding factor to risk of preterm delivery.
 
A positive result between 24-34 weeks of gestation suggests a 12-16% chance of preterm delivery within the next 7-14 days. A negative/non-detected test result rules out preterm delivery with 99% confidence within the next 14 days following sampling.​
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
82731 ​ ​ ​ ​ ​
Synonyms/Keywords
Fibronectin, Fetal, FFN​
Ordering Applications
Ordering Application Description
​Centricity

​a. Fetal Fibronectin

b. Fetal Fibronectin (FFN)

​Cerner ​Fetal Fibronectin
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No​ Cervicovaginal secretions​
Cytyc (formerly Adeza) collection kit containing a polyester tipped applicator and transport vial with buffer
 
Contact laboratory for kit​
 ​
1 swab in buffer​
 ​ ​
Collection Processing
Only samples collected using the Cytyc kits will be accepted.
 
During a sterile speculum examination, insert the applicator and lightly rotate across the posterior formix or around the ectocervical region of the external cervical os for approximately 10 seconds. Remove the swab and immerse swab tip in buffer. Break the shaft of the swab even with the top of the tube. Align the shaft with the hole inside the tube cap. Seal tube with cap and send to the laboratory as soon as possible.

Specimen should be obtained prior to digital exam or vaginal probe ultrasound as manipulation of the cervix may cause release of fetal fibronectin. Do not contaminate the sample or swab with lubricants (K-Y Jelly), soaps, or disinfectants (eg. Betadine). Patient should not have had sexual intercourse within the 24-hour period prior to sampling (potential for a false positive).​

For more information on Specimen Collection Media/Swab, see Specimen Transport Pictorial.
Acceptable Body Sites
Cervical​
Specimen Stability Information
Specimen Type Temperature Time
Cervicovaginal secretions in Cytyc kits ​ Ambient​ 8 hours​
Cervicovaginal secretions in Cytyc kits​ Refrigerated​ 72 hours​
Cervicovaginal secretions in Cytyc kits​ Frozen​ 3 months​
Rejection Criteria
Samples collected with any other type of collection devices
Moderately or grossly bloody​
Contaminated with lubricants, soaps, or disinfectants​
Interference
Assay interference from the following components has not been ruled out: douches, WBCs, RBCs, bacteria and bilirubin.
 
Care must be taken not to contaminate the swab or cervico-vaginal secretions with lubricants, soaps, or disinfectants (e.g., K-Y® Jelly lubricant, Betadine® disinfectant, Monistat® cream). These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of the Rapid fFN assay.
 
Test results are difficult to interpret if the specimen contains semen or if the specimen was collected less than 24 hours after intercourse.​
Useful For
The Rapid fFN assay is useful for assessing the risk of pre-term delivery in primarily symptomatic women but also asymptomatic women with a history of pre-term labor symptoms.​
Reference Range Information
Performing Location Reference Range
All Performing Sites Non-detected (Negative)​
Interpretation
The presence of infections has not been ruled out as a confounding factor to risk of preterm delivery.
 
A positive result between 24-34 weeks of gestation suggests a 12-16% chance of preterm delivery within the next 7-14 days. A negative/non-detected test result rules out preterm delivery with 99% confidence within the next 14 days following sampling.​
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Diagnostic Treatment Center​ ​Monday through Sunday​ ​Less than 2 hours​ ​Solid Phase Immunochromatographic Assay/Hologic Inc
​Eau Claire ​Monday through Sunday ​Less than 2 hours ​Lateral Flow Solid Phase Immunochromatographic Assay/Hologic Inc
​Lakeview Medical Center ​Monday through Sunday​ ​Less than 2 hours​ ​Lateral Flow Solid Phase Immunochromatographic Assay/Hologic Inc
Marshfield​ Monday through Sunday​ Less than 2 hours​ Lateral Flow Solid Phase Immunochromatographic Assay/Hologic Inc
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
82731 ​ ​ ​ ​ ​
For most current information refer to the Marshfield Laboratory online reference manual.