INTENDED USE

The FFN Rapid Test Device (Female cervix) is a rapid one step assay designed for semiquantitative detection of Fetal fibronectin in female cervix.The FFN Rapid Test Device (Female cervix) is mainly used to evaluate whether pregnant women are at risk of premature birth. For professional in vitro diagnostic use only.

SUMMARY

Fetal fibronectin testing is used to assess the risk of preterm delivery in pregnant women. In the second and third trimester of pregnancy, fetal fibronectin test results are positive or more than 50ng/ml, indicating a higher risk of preterm birth, but if a positive result is followed by a negative result, indicating a reduced risk of preterm birth, two negative results, the risk is reduced to normal levels. In addition, high levels of fetal fibronectin also play an important role in the development of diseases such as amniotitis and postpartum sepsis.

PRINCIPLES

The FFN Rapid Test Device (Female cervix) is an immunochromatographic test, based on two specific antibodies against human FFN. The concentration-dependent formation of test lines allows a rapid semiquantitative determination of FFN in female cervix samples.
The tip of the test strip is dipped into the test sample which is diluted with buffer solution. The sample now moves through the test strip from bottom to top. If the test sample contains FFN, it attaches to the first anti-FFN antibody which is conjugated with a red gold colloidal for color marking. The red FFN antibody-gold complex, together with the sample liquid, diffuses through the membrane that is pre dispensed with lines of different amounts of the second anti-FFN antibody. The FFN-antibody-gold complex is immobilized by the antibodies coated on the membrane leading to the formation of red lines. The number of lines depends on the FFN concentration in the sample.When the FFN content in the sample exceeds 50ng/ml, the red line appears, and the higher the content, the more obvious the red line becomes.
The control line serves as a procedural control and indicates that sufficient volume of specimen has been added and membrane wicking has occurred.