[Product Name]

Generic name: Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochromatography)
[Packaging Size]
5 tests/kit, 20 tests/kit

[Intended Use]

This product is used for in vitro qualitative detection of Insulin-like growth factor binding protein-1 in human vaginal secretion samples.
IGFBP-1 mainly exists in amniotic fluid and is synthesized from decidual cells. The concentration of IGFBP-1 in amniotic fluid is 100-1000 times higher than that in blood. During the premature rupture of fetal membranes or being parturient, decidua and chorion are separated, and decidual cell debris is leaked into cervical mucus. IGFBP-1 in cervical vaginal secretions can be used as an objective indicator for the diagnosis of the premature rupture of fetal membranes.

Insulin-like growth factor binding protein-1 is a characteristic protein of amniotic fluid, the content of which is very low in vaginal secretions of normal pregnant women. Only when the fetal membrane ruptures and the amniotic fluid leaks into the vagina of pregnant women, the content of IGFBP-1 in vaginal secretions will increase. Therefore, an auxiliary diagnosis is provided by detecting IGFBP-1 in vaginal secretions for whether there is fetal membrane rupture (including premature rupture of fetal membranes) of pregnant women.

[Test Principles]

The product uses immunochromatography principle, using tracer labeling IGFBP-1 antibody as detection antibody, using IGFBP-1 antibody coating as capture antibody. When testing, if there is a certain concentration of IGFBP-1 in the sample to be tested, IGFBP-1 binds to the labeled IGFBP-1 antibody to form antigen-antibody complexes, which is captured by the coating antibody under the action of chromatography, thus showing a red band. When the sample to be tested does not contain IGFBP-1, it will not form antibody-antigen labeled complexes, nor will it be captured by the test line to produce red bands. Regardless of whether the sample contains the antibody to be tested, a red band should appear at the quality control line C as the internal control of whether the chromatography process is normal and whether the reagent is invalid.

[Storage Conditions and Shelf-life]

Storage Conditions: 4-30°C.
Shelf-life: 12 months.
See label for production and expiry dates.
The test cassette should be used within 60 minutes after being taken out of the aluminum foil bag.