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iGFBP-1 Rapid Test
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SUMMARY
Insulin-like growth factor-binding protein 1 (IBP-1) known as placental protein 12 (PP12) is a protein that in humans is encoded by the IGFBP1 gene. IGF-binding proteins (IGFBPs) is believed to be important in the regulation of fetal and neonatal growth.The Insulin-like growth factor-binding protein 1 (iGFBP-1) rapid test (vaginal secretion) is a visually interpreted, qualitative immunochromatographic test device for detection of iGFBP-1 in vaginal secretions during pregnancy, which is a major protein marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.

DIRECTIONS FOR USE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test cassette with patient or control identification. To obtain a best result, the assay should be performed within one hour.

2. Insert the swab into the dilution tube, rotate for 20 times. Then press the swab against the side of the tube and squeeze the bottom of the tube as the swab is withdrawn. Discard the swab.

3. Fit the cap onto the tube. Remove the top part of the cap. Place the test cassette on a clean and level surface. Add 3 full drops of solution (approx. 100 µL) to the specimen well (S), and then start the timer.

4. Wait for the colored band to appear. The result should be read at 5 minutes. Do not interpret the result after 20 minutes.