Fluorescent Immunoassay FFN POCT Kit

Intended use

This Fluorescent Immunoassay fFN POCT Kit is designed for in vitro quantitative detection of fFN in vaginal secretions samples. It’s for professional only.

Summary

fFN, the abbreviation of fetal Fibronectin, is an extracellular matrix glycoprotein produced by decidua and villi, which mainly plays the role of adhesion between placenta and decidua, and fFN can be positive before 20 weeks of pregnancy and before delivery. During the 22-35 weeks of pregnancy, the fetal membrane and decidua are completely fused. Under normal circumstances, the fFN detection should be <50ng/mL. If the fetal membrane and decidua are separated, the fFN detection result can exceed 50ng/mL.

Principle

The fluorescent immunoassay fFN POCT kit adopts microfluidic fluorescence immunoluminescence method, which helps get more accurate fFN level results in 10 minutes.

Why Test fFN?

Fetal fibronectin (fFN) is a reliable test to identify if pregnant women between 22 weeks and 35weeks of pregnancy who are most at risk for preterm birth and are having symptoms of premature labor will delivery preterm within the next 7-14 days, which is for reducing the risk of preterm birth.

If fFN is present in vaginal discharge, it is highly correlated with preterm birth.After 24 weeks, under normal circumstances, fibronectin should not be detected in the secretion of the vaginal posterior curvature (fibronectin <50) The positive fibronectin in the vaginal posterior curvature secretion in the first trimester is caused by the separation of chorion and decidua. Fibronectin leaks into vaginal fornix discharge.

The detection by the fluorescent immunoassay fFN POCT kit can have negative and positive result. A negative result ,which is of great value in clinical use to rule out preterm birth,indicates that although there are symptoms of threatened preterm labor, the possibility of delivery in the near future is low as follows:

1.The probability of not giving birth within 1 week is 98%

2.The probability of not giving birth within 2 weeks is 95%

A positive result means:

1. Pregnant women with threatened premature delivery are more likely to give birth in the near future (the sensitivity is about 50%, and the sensitivity of giving birth within one week is 71%)

2.Pregnant women without threatened preterm symptoms have an increased risk of premature delivery.

A positive result doesn’t guarantee an early birth. It simply allows the provider to monitor more closely and offer any necessary treatment.

Q: Is it possible for a false positive?

A:Sex or pelvic exams within 24 hours can lead to false-positive fFN test results.

Q: When to test?

A: In the 22nd to 34th week of pregnancy, fFN testing can be applied for when one or more symptoms suggest that premature delivery may occur. These symptoms include: uterine contractions, abnormal vaginal discharge, back pain, abdominal discomfort, pelvic pressure and/or cramping.

Q: How to avoid a false positive test ?

A:In order to take an accurate test, the follows are strongly suggested:

1.Before sampling, there should be no other vaginal operations and no history of sexual intercourse within 24 hours.

2.Pregnant women with a dilated cervix or severe vaginal bleeding should not be tested for fFN.

3.The test shall be done before any pelvic exam or transvaginal ultrasound.

Q: Are there other markers to detect premature?

A: Yes,we offer PAMA-I ,IGFBP-I,PLGF and SFLT-1,β-HCG to detect On-demand.

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