Pregnancy test kit

IGFBP-1vaginal secretionsamniotic fluid

Product overview
The iGFBP-1 test (vaginal secretion) is a rapid chromatographic immunoassay for qualitative detection of iGFBP-1 by visual interpretation of color development on an internal membrane. The test region of the membrane is immobilized with anti-iGFBP-1 antibodies. During the assay, the specimen reacts with colored anti-iGFBP-1 antibody–colloidal gold conjugates pre-coated on the sample pad. The complex migrates along the membrane by capillary action and produces a colored band at the test region if iGFBP-1 concentration meets or exceeds the cutoff. A colored band at the control region confirms valid procedural performance.

Intended use
Rapid diagnostic test for detection of iGFBP-1 in vaginal secretions to aid screening related to preterm labor risk.

Operating steps

• Bring test devices, specimens, buffer and controls to room temperature (15–30 °C) before use.
• Open the sealed pouch and place the device on a clean, level surface. Label with patient or control identification and perform the assay within one hour of opening.
• Add the extracted buffer/specimen into the sample well; color will migrate across the membrane as the test runs.
• Read the result at 10 minutes. Do not interpret results after 20 minutes.

Components

• Individually packed test devices
• Specimen collection swab
• Specimen dilution tube with buffer
• Disposable pipettes
• Package insert

Technical specifications

• Product: iGFBP-1 rapid test kit
• Specimen: Vaginal secretion
• Cutoff: 25 ng/ml
• Accuracy: >99%
• Formats: Strip, cassette
• Storage temperature: 2–30 °C
• Shelf life: 24 months
• Result interpretation time: read at 10 minutes; do not interpret after 20 minutes