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QUICKCHECK FFN

QuikCheck fFN test

QuikCheck fFN test is a diagnostic test that examines the level of fetal fibronectin a pregnant woman has and can accurately assess the possibility of a preterm labor.

The test application is quick and simple. The sample is collected during a routine visit to the doctor’s office and the results are assessed within 15 minutes.


The cervicovaginal test for fetal Fibronectin is a method to assess preterm labor risk, which, due to its easy and simple clinical application, has been very well received.

Fetal Fibronectin (fFn) is an accurate biomarker for preterm labor risk assessment. fFn levels in cervicovaginal secretions is highly associated with preterm labor.

In normal pregnancies, fFn concentration in cervicovaginal liquids is 50ng/ml between weeks 22 and 35 of gestation. Higher values during these weeks show a high risk of preterm labor.


The test for assessing the danger of preterm labor has been approved by the FDA for use:

  • on women with symptoms from the 24th to the 35th week of gestation,
  • on women with no symptoms from the 22nd to the 31st week of gestation.

QuikCheck fFN test assesses risk of miscarriage for symptomatic women in less or up to 7 days from ample collection and for asymptomatic women in less or up to 14 days from ample collection before the 35th week of gestation.

Samlple collection:

fFN test sample is collected during a routine examination in the doctor’s office. It has to precede any other examination. The doctor introduces the dipstick (speculum exam) and collects the sample by rotating the stick for 10 seconds from the posterior fornix of the vagina or from the ectocervix. Then the doctor inserts the dipstick in the collection tube which contains a liquid, mixes the dipstick in the solution, waits for 10 minutes and then reads the result on the dipstick. One line shows that the fFn levels are below 50ng/ml, therefore the test is negative. Two lines show that the fFn levels are above 50ng/ml, therefore the test is positive.


SYMPTOMATIC WOMEN

Negative testPositive test
Possibility <1% for preterm labor for the next 14 days

If there are no other risk factors, a negative test shows reduced risk of preterm labor
16.7% of women will deliver prematurely in the next 14 days (4 times more reliable prediction for preterm labor compared to no testing)
The test has 99.2% negative prognostic value for preterm labor within the next 14 days and 99.5% for miscarriage within the next 7 days (High negative predictive value = high specificity)
BenefitBenefit
1. Helps avoid unnecessary hospital charges, tests and extensive stay at home

2. Reduces or limits unnecessary operations and helps more rational use of tocolytic drugs so they can be used when it is more necessary

3. Reassures women that they will not prematurely deliver within the next 7 or 14 days

4. Reduces costs of possible hospitalization
1. Doctor's recommendations for increased attention, care and rest

2. Treatment with drugs such as corticosteroids, antibiotics, tocolytics and hospitalization

ASYMTOMATIC WOMEN

Negative testPositive test
The test (performed on week 24) has 99.7% negative prognostic value for miscarriage before the 28th week and 96.3% before the 35th week31.7% of women will miscarry before week 35 (this represents 7 time better accuracy for preterm labor prediction)
BenefitBenefit
1. Relieves women from uncertainty

2. Reduces of limits hospitalization

3. Reassures women that they will not prematurely deliver before week 34

4. Helps avoid unnecessary recommendations to women for staying at home and interrupting their work
1. Increases frequency and intensity of prenatal control

2. Helps co-evaluation of other risk factors

3. Women's training

4. Possible premature interventions

―  Preterm labor

Preterm labor happens between week 20 and week 37 of gestation.

For births before week 37 preterm labor rate is 12% in the US, while for births before week 34, it is 3-4%. Newborn death rate is70% for births under the 29th week of gestation, in other words 2 out of 3 premature babies die. It is estimated that 49% of premature babies that survive develop some kind of disability (mental retardation, blindness) 1.

While many preterm labors happen to women of high risk groups, more than 50% of mothers that had premature labor did not show any risk factors 2.

Fetal Fibronectin test is used to assess with great safety the real risk for preterm labor. For example, if a symptomatic woman’s test is negative, it is less than 1% possible that she will prematurely deliver within the next 14 days 3.


Source:

1 http://www.acog.org/Womens-Health/Preterm-Premature-Labor-and-Birth, http://www.marchofdimes.org/
2 http://www.ffntest.com/why_it_matters.html
3 Adeza. Fetal fibronectin enzyme immunoassay and Rapid fFN for the TLiIQ® System: Information for healthcare providers, December 2003. (Based on data from NICHD Preterm Prediction Study)


We represent and manage this innovative product of Hologic Inc by distributing in the Greek market the accessories and the know-how of Fetal Fibronectin Test Quick Check fFN.

For more information on QuikCheck fFn :

diagnostics@aenorasis.com


The information referred to for general information and informing the public and in any case can not replace a doctor or other suitably qualified health professional. The responsibility of the media carries by ENORASIS SA