1. Fetal Fibronectin Testing for Suspected Preterm Labour
An emerging standard of care
(Note: Please feel free to use your own background design)

2. Fetal Fibronectin Testing for Suspected Preterm Labour
Objectives
Discuss incidence of preterm labour provincially and nationally
Describe the benefits of fetal fibronectin testing
Outline insert province approach to this emerging standard of care
Provide detailed clinical decision making and procedures for fFN testing

3. Preterm Labour (< 37 weeks)
1 in 5 pregnant women exhibit signs and symptoms of preterm labour.
3-4 % of births occur before 34 weeks
Up to 70% of women identified as “high-risk” deliver at term.
Maximum clinical judgment sensitivity for del <1week from admission was <50% with minimal cervical dilatation (< 3 cm.).

4. Preterm Birth
Preterm birth rate is defined as the number of live births with a gestational age less than 37 weeks completed weeks gestation
>7.6% (all Provinces) of all pregnancies result in preterm birth
Sources: ACOG Technical Bulletin,1995, No. 206; National Vital Statistics Report 2000;48(3). St John EB et al. Am J Obstet Gynecol. 2000;182: Macones, Am J ObGyn, Vol 181, 12/99

5. Rate of Preterm Delivery by Province/Territory (excluding Ontario) 2000

6. Add own provincial data

7. The Challenge…
The preterm birth rate has not decreased in the last thirty years!!!

8. 20 percent increase
Source: CPSS Report p. 74

9. How do we identify who is at Risk?
Preterm Birth
How do we identify who is at Risk?
Cervical
Length
Symptoms
of PTL
Risk
Factors
Fetal
Fibronectin

10. Prevention/Intervention Strategies
Hydration
Tocolytics
Bedrest
Education
Targeting
High Risk
Women
Home
Uterine
Monitoring
Frequent
Digital
Exam
Population
Based
strategies

11. Risk Assessment Markers
Biophysical markers
Measurement of cervical length
Biochemical markers
Fetal fibronectin (fFN)
Salivary estriol (E3)
Corticotropin-releasing hormone (CRH)
Interleukin-6 (IL-6)

12. Potential Benefits of An Evidence-Based, Risk Assessment Marker
Identify women who are truly at risk.
Identify and reassure women who are not at risk.
Avoid separation of mother from her family.
Avoid unnecessary expense of extended assessment time, admission time, transport to a tertiary centre.
Avoid unnecessary tocolytic and steriod use.
Improved resource utilization.
Potential research benefits e.g. focus tocolytic trials on women who will potentially benefit.

13. Fetal Fibronectin (ƒFN)
Fetal Fibronectin (fFN) is not new in obstetrics practice
1st literature appeared in 1985; as an oncogene marker.
1st OB-specific literature appeared in 1991 in New England J. of Medicine by Lockwood, et al.
>200 peer reviewed OB articles now published, 3 meta analyses, 9 Canada-specific abstracts presented at SOGC.
Canada specific data documents reduced medication use, reduced hospital day stays, reduced transports
Canadian data is from level III hospitals, rural and remote hospitals.

14. What is Fetal Fibronectin (ƒFN)
Glycoprotein found in extracellular matrix of amniotic membranes.
Binds chorion to decidua.
Normally found in cervico-vaginal secretions until 22 weeks gestation and again near the time of labour.
Released into cervical/vaginal fluid in response to inflammation or separation of amniotic membranes from decidua.
Presence after 24 weeks is indicative of imminent labour
Fetal (ƒFN) immunoassay detects concentrations of fetal fibronectin protein in cervicovaginal fluids.
Presence of >50 ng/mL considered positive.

15. Fetal Fibronectin (ƒFN)

16. Normal ƒFN Expression by Gestational Age

17. Key Terminology for Evaluating PTD Diagnostics
Negative Predictive Value (NPV): Answers the question, “If a woman has a negative test, how likely is she NOT to deliver prematurely?”
Positive Predictive Value (PPV): Answers the question, “If a woman has a positive test, how likely is she to deliver prematurely?”
Sensitivity: Percent of women who have preterm delivery whom the test correctly identifies
Specificity: Percent of women who do NOT have preterm delivery whom the test correctly identifies

18. Utility of ƒFN for Predicting PTB in Symptomatic Women
PPV(%) NPV(%) Cx Dilatation(cm)
Lockwood, 1991 (n=117) None
Morrison, 1993 (n=28)  1
Iams, 1995 (n=192)  3
Burrus, 1995 (n=37)  3
Bartnicki, 1996 (n=112)  2
Peaceman, 1997 (n=725)  3

19. Threatened Preterm Labour
Women with
Threatened Preterm Labour
(1/25 deliver <14 days)
ƒFN -
(80%)
ƒFN +
(20%)
1/125
Deliver <14 days
1/6
Deliver <14 days
Peaceman, AJOG 1997; 177:13-8

20. Nova Scotia Pilot Study April 2002-March 2004 (Armson & Scott et. al.)
Prospective cohort study
Objectives
To determine if introduction of rapid ƒFN testing for suspected PTL will:
Reliably predict preterm birth
Result in a reduction of:
PTL admissions/maternal transfer rates
length of stay, tocolytic/corticosteroid use
reproductive health care costs without compromising neonatal outcomes

21. Conclusions from Nova Scotia Study
A negative ƒFN test for suspected PTL accurately identifies women not likely to deliver within 14 days (98% -99% accurate)
A positive ƒFN test identifies women at high risk for preterm birth
- 24%  7 days
- 28%  14 days
- 31%  34 weeks
- 48%  37 weeks
Diagnostic accuracy of ƒFN superior to clinical criteria for women with suspected preterm labour

22. Conclusions from Nova Scotia Study
Criteria for clinical use of ƒFN appear to be broad and inconsistent
Clinicians/patients somewhat reluctant to adhere to guidelines of non-intervention for negative ƒFN results, particularly in regional centres.
Potential for reduction in maternal transfers, hospital admissions and associated health care costs

23. Results from the Nova Scotia Study
Implementation of province-wide Fetal Fibronectin testing currently ongoing
Seed funding provided by NS Department of Health
Goals
To reduce unnecessary maternal transfers and admissions for suspected preterm labour
To reduce psychosocial and financial burdens for families

24. BC Study
Fetal Fibronectin collected by speculum exam from admitted patients with symptomatic preterm labour
Assays were performed in our laboratory. The results were revealed to the clinician within 1 – 8 hours
A retrospective chart review was undertaken to assess pregnancy outcome
An estimate of the total hospital days saved was developed using the ALOS for patients admitted with a diagnosis of PTL prior to the utilization of the Fetal Fibronectin Assay

25. Results Of 62 patients tested, outcomes were known for 47 patients.
Delivered < 14 days
Delivered > 14 days
FFN +ve 1 7 1 38
FFN –ve
Sensitivity = 50% PPV = 12.5%
Specificity = 84% NPV = 97%
Farquharson, D., Lee, L.,Garg, A. Clinical utilization and cost saving analysis of fetal fibronectin assay in a tertiary care institution. Abstracted presented at 2003 SOGC meeting, Charlottetown.

26. BC Study Results
A total of 62 assays were conducted between May 2002 and March 2003
Ages 18 – 39, mean 30
GA on admission: 20 – 33 weeks
Length of stay ranged 1 – 44 days, mean 4.7 days
Nulliparas: 55 %
Multiparas: 45 %

27. BC Study Conclusion
Our experience in which Fetal Fibronectin Assay (Adeza TLI) was used as an adjunct to diagnosis and management of preterm labour suggest reduced hospital utilization, and earlier reverse transfer of these patients to their referring institutions without adverse sequelae.

28. Cost Savings (literature)
Reduction in PTL admissions
$486,000 saved
(Joffe et al, AJOG 1999)
Reduction in maternal transfers
$30,297 saved
(Giles et al, AJOG 2000)

29. Resource Utilization - Canada
Royal Victoria Hospital
Observational cohort design
20 week periods before and after ƒFN
Singletons, weeks, suspected PTL
Abenhaim JOGC 2005; 27:689-94

30. Effect of ƒFN on Resource Utilization
_________________________________________________________
Baseline Period Study Period p value _________________________________________________________
Patients
Preterm Births 9 (7.8%) (8.6%) NS
PTL Admissions 28 (24.1%) (12.1%) 0.02
Days Hospitalized
Mean LOS
Admission Costs $102, $26,169
Mean Cost $3, $
Abenhaim, JOGC 2005; 27:689-94

31. Considerations Cost: Approximately $100+ per test
Patient demand – not experienced by other centres
Physician overuse
Estimate per years based on 2500 births/yr
Close adherence to guideline
Savings
Cost of admission
Cost of transfer
Optimal use of tertiary beds
Maternal/family reassurance/satisfaction

32. Patient <34 wks Gestation with Symptoms of Preterm Labour
Network organizations will facilitate a supportive environment for adoption of CHN Practice Guidelines by incorporating the guidelines into their existing guideline process (order sets, intranet availability, etc).
Network organizations will identify a “champion” to take the lead in ensuring implementation of the guideline at the organization.
The CHN guideline will proceed through the organizational process for “approval” (MAC, Pharmacy, etc).
Education sessions will be provided for staff. CHN will provide a Power Point Presentation for organizational use.
CHN will monitor implementation through a variety of methods and report to members (surveys, chart audits, etc).
Patient <34 wks Gestation with Symptoms of Preterm Labour
Speculum exam before VE
fFN swab from posterior fornix
(see Appendix A)
Cultures
Management of PROM
Discard fFN swab
Evidence of Ruptured Membranes
Intact Membranes
Vaginal Examination
Cx ≥ 3 cm Dilation
Regular uterine activity
Diagnosis preterm labour
Treat for preterm labour
Send fFN swab
Reassure mother
Cx < 3 cm dilated
Ongoing uterine activity
Clinical suspicion of preterm labour
Cx Long + closed
Contractions subsided
No clinical evidence of preterm labour
Positive
Tocolytics
Corticosteroids
Antibiotics
Consider transfer to appropriate level of care
Negative
F/U endovaginal ultrasound of the cervix (if available)
Treatment of BV
Consider repeat test in 7-14 days, if symptomatic
Regular uterine contractions >6 per hour
Pelvic pressure
Low abdominal pain and/or cramps
Low backache
Fetal Fibronectin
Guideline for Use in the Management of Preterm Labour
Practice Guideline
June 2006
Background
A guideline addressing the use of the Fetal Fibronectin (fFN) test for women in preterm labour was recommended by members of the Child Health Network for the Greater Toronto Area during the operating plan consultation process. Members of the Maternal Newborn Task Force believed that the test had the potential to avert maternal transfers from regional and community hospitals and optimize the use of tertiary antenatal and neonatal beds. It was also expected that admissions to both community and regional hospitals could be also be reduced as physicians could be assured that mothers with a negative fFNtest would not deliver their babies within 14 days..
The original draft was developed by an expert panel[1] and will be distributed for comment and input. The final guideline will be developed after discussion of the comments from the membership of the Network.
Implementation of the guideline will follow the approved process for guideline implementation as determined by the Board of Directors in December Briefly, the following steps will be followed during the implementation of the guideline throughout the Network:
Introduction
Fetal Fibronectin (fFN) is a glycoprotein produced by the chorionic membranes and is localized to the deciduas basalis adjacent to the intervillous space. Its primary purpose appears to be that of an adhesion molecule (tissue glue) which helps bind the chorionic membranes to the underlying maternal decidua. It is normally found in cervico-vaginal secretions until 22 weeks gestation but is virtually never found between 24 and 34 weeks gestation unless the cervix has undergone premature effacement and dilatation, usually in association with symptomatic uterine contractions. It can also be released in response to inflammation or separation of amniotic membranes from the deciduas. There is a strong association between the presence of Fetal Fibronectin in cervico-vaginal secretions and preterm labour after 24 weeks gestation.
Expert Panel Discussion/Literature Review
The expert panel reviewed the literature[2] provided in the package provided by the CHN. Trials have shown an association between the presence of fFN and preterm birth as well as a decrease in the risk of preterm birth when tests are negative for the presence of fFN. The literature was judged to be conclusive for the negative predictive value of the fFN test. A negative test confers a more than 95% likelihood of the woman remaining undelivered for the 14 days following a negative test result.
The Expert Panel heard a presentation from Dr. Ford Luk, chief of obstetrics from York Central Hospital, who presented results on 35 women who had received the test at York Central and showed similar negative predictability reported in the literature as well as cost savings from the reduced admissions to the antenatal and birthing unit. This small sample of experience from the GTA was helpful for the Expert Panel to consider. Additional literature reflecting Canadian experience with the Fetal Fibronectin Test confirmed the utility and predictive value of the test.
Agreement to proceed with the recommendation for use of fFN in Network Hospitals was reached. The following are the recommendations of the Panel:
Purpose of the Fetal Fibronectin Test:
The purpose of testing for Fetal Fibronectin in women with symptoms of premature labour is to:
Prevent unnecessary admissions to community, regional and tertiary hospitals
Prevent unnecessary transfers of mothers with symptoms of preterm labour to tertiary or regional centres
Decrease the numbers of out-of-region transfers
Decrease costs associated with an admission to a tertiary (or community and regional hospital) especially those related to a stay in the birthing unit
Provide reassurance to mothers and their families that birth of their baby prematurely is highly unlikely within fourteen days of the onset of symptoms when the test is negative.
General Recommendations:[3]
All women presenting in the Emergency Department or Birthing Unit with one or more signs/symptoms of threatened preterm labour ( Figure 1) should have a mandatory consult with a obstetrician who will perform an assessment of the patient and may order the test.
Figure 1 Signs of Threatened Preterm Labour
NOTE: PRIOR TO ANY VAGINAL EXAMINATION, A SPECULUM EXAM SHOULD BE DONE AND THE SWAB FOR FETAL FIBRONECTIN OBTAINED. THE DECISION TO SEND THE SWAB FOR TESTING CAN BE MADE ONCE THE PATIENT PHYSICAL ASSESSMENT IS COMPLETE.
Indications for Testing
Intended transfer of women between 24 and 34 completed weeks
to a tertiary unit or regional unit, for example,
Threatened preterm labour (Figure 1)
Intact amniotic membranes
Cervix <3 cm dilatation
Established fetal well-being
Intended admission of women between 32 and 34 completed weeks to a community or regional hospital with the above symptoms of preterm labour
Intended administration of antenatal corticosteroids
Contraindications for Testing
Estimated gestational age (EGA) <24 weeks or >34 completed weeks
Preterm rupture of membranes (PROM)
Cervix ≥3 cm dilatation
Cervical cerclage
Active vaginal bleeding
Vaginal exam or sexual intercourse in the past 24 hours
Specimen Collection
Use only the ADEZA Fetal Fibronectin Kit
Equipment required includes the swab, collection tube, tube cap, test cartridge and instrument based system to perform the fFN test.
Collect specimen during a speculum exam with special fFN swab using an unlubricated speculum
Speculum exam must occur before vaginal ultrasound, before digital examination and without the use of lubricants (all can alter predictability of the test)
If any of the above exams have taken place, wait 24 hours and then obtain the test
If test cannot be performed within 8 hours of collection, refrigerate specimen until test is performed
Perform test within 3 days of specimen collection
NOTE: Once the swab has been obtained, if subsequent physical exam does not indicate that there are sufficient signs of preterm labour (or if other contraindications are present i.e., ruptured membranes, cervical dilatation > 3 cm, etc.), the swab should be discarded and the test NOT performed
Test Results
Positive ≥ 50 ng/ml
Negative ≤ 50 ng/ml
Factors Affecting Accuracy of the Test
False positive tests may be caused by:
Digital exam prior to the speculum collection of the sample
More than a minimal amount of blood in the specimen (fFN is present in plasma)
The presence of amniotic fluid in the specimen(amniotic fluid contains high levels of fFN)
Intercourse within the previous 24 hours (fFN is present in seminal fluid)
False negative tests may be caused by:
Presence of a lubricant on the speculum
Positive Test Result
Indicates a higher risk of preterm delivery
Consider:
Admission or transfer of the woman to an appropriate facility for treatment of preterm labour and possible delivery of a preterm baby
<32 weeks – Tertiary centre
≥32 weeks – Level 2 or Level 2+ centre
Administration of tocolytics and/or corticosteroids as indicated
Negative Test Result
Indicates that delivery will not take place within 7-14 days (>95% accuracy)
Discharge home with instructions to return if symptoms worsen and limit activities that aggravate her symptoms if geographical, weather and other medical circumstances permit
Close follow up care may include a vaginal ultrasound to assess cervical length (If cervical length is >2.5 cm it provides further reassurance that delivery will not occur preterm) +/- a swab for bacterial vaginosis.
Re-evaluate in 7-14 days
Patient Education
The purpose and function of the test should be explained to each patient in order to decrease ‘patient demand” for the test in subsequent weeks
Evaluation/Audit
An audit tool monitoring the following parameters will be submitted to the Maternal/Newborn Task Force of the CHN for a quarterly report on the use and reliability of the test as well as the impacts on the CHN perinatal system. The following indicators will be monitored:
The number of fFN tests performed by organization, level of care and as a whole
The number of negative/positive tests recorded
The number of transfers of others to network hospitals for the diagnosis of premature labour
The number of transfers avoided through negative test results
Estimated cost of the test to the system (# of tests performed multiplied by the cost of the test)
Estimated savings to the system days avoided by use of test)
Patient days for admission for preterm labour and compare to retrospective patient days in previous year prior to implementation of the fFN test
Flowchart
Fetal Fibronectin Testing for Suspected Preterm Labour
References:
Abenhaim HA, Morin L, Benjamin A. Does Availability of Fetal Fibronectin Testing in the Management of threatened Preterm Labour Affect the Utilization of Hospital Resources? J Obstet Gynaecol Can 2005;27(7):
ACOG Practice Bulletin. Assessment of Risk Factors for Preterm Birth. October 2001
Anderson HF. Use of Fetal fibronectin in Women at Risk For Preterm labor. Clinical obstetrics and Gynecology;43(4):
Armson BA, Dodds L, Dooley K, Howlett A, McPhee A, Scott H. Fetal Fibronectin Testing for Suspected Preterm labour in Nova Scotia. Am J Obstet Gynecol 2004;191:S115
British Columbia Reproductive Care Program. Obstetric Guideline – Preterm Labour. February 2005
Colombo DF. Predicting spontaneous preterm birth. BMJ 2002;325:
Farquharson, D, Skoll A. Fetal Fibronectin. BCRCP Perspectives, Winter 2004
Garite TJ, Casal D, Garcia-Alonso A, Kreadon US, Jimenez G, Ayala JA, Reimbold T. Fetal fibronectin: A new tool for the prediction of successful induction of labor. Am J Obstet Gynecol 1996;175:
Giles W, Bisits A, Knox M, Madsen G, Smith R. The effect of fetal fibronectin testing on admissions to a tertiary maternal-fetal medicine unit and cost savings. Am J Obstet Gynecol 2000;182:
Goldenberg RL, Iams JD, Das A, Mercer BM, Meis PJ, Moawad Ah, Miodovnik M, VanDorsten JP, Caritis SN, Thurnau, Dombrowski MP, Roberts JM, McNellis D. The Preterm Predeiction Study: Sequential cervical length and fetal fibronectin testing for the prediction of spontaneous preterm birth. Am J Obstet Gynecol 2000;182:
Goldenberg RL, Mercer BM, Iams JD, Moawad AH, Meis PJ, Das A, McNellis D, Miodovnik M, Menard MK, Caritis SN, Thurnau GR, Bottoms SF. The preterm prediction study: Patterns of cervicalvaginal fetal fibronectin as predictors of spontaneous preterm delivery. Am J Obstet Gynecol 1997; 177:8-12.
Honest H, Bachmann LM, Gupta JK, Kleijen J, Khan KS. Accuracy of cervicvaginal fetal fibronectin test in predicting risk of spontaneous preterm birth: systematic review. BMJ 2002;325:
Iams JD. Prediction and Early Detection of Preterm Labor. Obstet Gynecol 2003;101:
Iams JD, Casal D, McGregor JA, Goodwin TM, Kreadon US, Lowensohn R, Lockitch G. Fetal fibronectin improves the accuracy of diagnosis of preterm labor. Am J Obstet Gynecol 1995;173:141-5.
Joffe GM, Jacques D, Bemis-Heys R, Burton R, Skram B, Shelburne P. Impact of the fetal fibronectin assay on admissions for preterm labour. Am J Obstet Gynecol 1999;180:581-6.
Lopez RL, Francis JA, Garite TJ, Dubyak JM. Fetal fibronectin detection as a predictor of preterm birth in actual clinical practice. Am J Obstet Gynecol 2000;182:
Lowe MP, Zimmerman B, Hansen W. Prospective randomized controlled trial of fetal fibronectin on preterm labor management in a tertiary care center. Am J Obstet Gynecol 2004;190:
Macones GA, Segal SY, Stamilio DM, Morgan MA. Prediction of delivery among women with early preterm labor by means of clinical characteristics alone. Am J Obstet Gynecol 1999;181:
Meis PJ, Goldenberg RL, Mercer BM, Iams JD, Moawad AH, Miodovnik M, Menard K, Caritis SN, Thurneau GR, Bottoms SF, Das A, Roberts JM, McNellis D. The preterm prediction study: Risk factors fro indicated preterm births. Am J Obstet Gynecol 1998;178:562-7.
Mozurkewich EL, Naglie G, Krahn MD, Hayashi RH. Predicting preterm birth: A cost-effective analysis. Am J Obstet Gynecol 2000;182:
Peaseman AM, Andrews WW, Thorp JM, Cliver SP, Lukes A, Iams JD, Coultrip L, Erikson N, Holbrook H, Elliot J, Ingardia C, Pietrantoni M. Fetal fibronectin as a predictor of preterm birth in patients with symptoms: A multicenter trial. Am J Obstet Gyncol 1997;177:13-18.
Plaut MM, Smith W, Kennedy K. Fetal fibronectin: The impact of a rapid test on the treatment of women with preterm labor symptoms. Am J Obstet Gynecol 2003;188:
Reis FM, Gervasi MT, Florio P, Bracalente G, Fadalti M, Severi FM, Petragalia F. Prediction of successful induction of labor at term: Role of clinical history, digital examination, ultrasound assessment of the cervix and fetal fibronectin assay. AmJ Obstet Gynecol 2003;189:1361-7
Rozenberg P, Goffinet F, Hessabi M. Comparison of the Bishop score, ultrasonographically measured cervical length and fetal fibronectin assay in predicting time until delivery and type of delivery at term. Am J Obstet Gynecol 2000;182:
APPENDIX 1
Expert Panel on Fetal Fibronectin
Members
Dr. Tony Addison Obstetrician William Osler Health Centre
Dr. Jon Barrett Obstetrician Sunnybrook & Women’s
Dr. Tatiana Friere-Lizamat Obstetrician St. Michael’s Hospital
Dr. Mathias Gysler Chief of Obstetrics Credit Valley Hospital
Ms. Kathryn Hayward Murray Nursing Director Credit Valley Hospital
Ms. Nazira Jaffer Director North York General Hospital
Ms. Moya Johnson Clinical Advisor Child Health Network
Dr. Terry Logaridis Chief of Obstetrics Rouge Valley Health System
Dr. Fork Luk Chief of Obstetrics York Central Hospital
Dr. Nan Okun Obstetrician Mount Sinai Hospital
Dr. Andrew Shennan VP Perinatal Services Sunnybrook & Women’s
Dr. Nick Shiletto Obstetrician North York General Hospital
Dr. Jonathan Tolkin Medical Advisor Child Health Network
Dr. Rory Windrim Obstetrician Mount Sinai Hospital
Dr. Suzanne Wong Deputy Chief of Obstetrics St. Joseph’s Health Centre
Tony Wong Laboratory York Central Hospital
[1] Appendix 1 – Members of CHN Expert Panel Fetal Fibronectin Test Guideline
[2] See References for a complete list of literature used by the Expert Panel.
[3] Based on BC Reproductive Care Guideline on Management of Preterm Labour see Reference # 5
fFN swab from posterior fornix (see Appendix A)
Cx < 3 cm Dilated
Cx Long + Closed
- Tocolytics
- Corticosteroids
- Antibiotics
Fetal Fibronectin Decision-Making Algorithm
BCRCP (2005) Obstetric Guideline 2A – Preterm Labour, p. 11

33. Guidelines for Use of fFN test
Specimen should not be obtained in presence of:
Cervical dilatation >3 cm
PROM
Soaps, gels, lubricants, or disinfectants
Cervical cerclage
Moderate or gross vaginal bleeding
Sexual intercourse within 24 hours
Obtain specimen prior to procedures that may disrupt cervix:
Digital examination
Vaginal ultrasound
Microbiologic culture
Pap smear
Source: Honest et.al. BMJ, Aug 2002

34. Specimen Collection for ƒFN Testing
Lightly rotate swab across either the posterior fornix of the vagina or the ectocervical region of the external cerical os for 10 seconds.

35. Specimen Collection for ƒFN Testing
Remove swab and immerse Dacron® tip in buffer
Break the shaft even with the top of the tube (at the score)

36. Specimen Collection for ƒFN Testing
Speaker Notes:
If the specimen is being transported to a central laboratory for analysis, place the tube on ice or store in a refrigerator at 2 to 8 degrees C. Do not freeze or expose the specimen to elevated temperatures.
Align the shaft with the hole inside the tube cap and push down tightly over the shaft to seal the tube.

37. Fetal Fibronectin (ƒFN) Test Results
Rapid fFN for the TLi™ System
Analyzer produces results in 23 minutes
Around-the-clock availability
Rapid fFN is run like a pregnancy test
Several sites in Canada run the assay in L&D
Speaker Notes:
With the Rapid fFN for the TLi™ System:
Rapid analyzer produces results in 20 to 30 minutes.
Based upon a laboratory’s capabilities and specimen transport times, test results are usually available in 2 to 4 hours.
If a Rapid fFN TLi™ System is not available in the area, tests may be analyzed in a central laboratory utilizing the fFN Enzyme Immunoassay.
Samples must be packed in ice and express shipped overnight to the central laboratory.
Results are typically available within 24 hours.

38. Implementation of fFN in insert province/territory or region

39. Conclusion
Fetal Fibronectin is a useful adjunct to diagnosis and manage preterm labour
Reduced hospital admission and transfers of women with symptoms of preterm labour.
Decreased costs associated with hospital admissions, transfers
Improved identification of women who need corticosteroid and tocolytic therapy
Provide reassurance to women and families

40. Questions?

41. Thank you!