Qualitative immunochromatographic test for in vitro detection of amniotic fluid in vaginal secretion of pregnant women.
Specification
The premature rupture of membranes or PROM is relatively frequent and concerns 5 to 10 % of pregnancy cases. It might lead to preterm delivery and fetal infection. The leakage of amniotic liquid is not always detectable by conventional clinical examination and confirmatory biological test is sometimes useful. Biological tests are based on vaginal detection of alkalinization (easy to proceed, sensitive, inexpensive but poorly specific) or presence of a molecule which is physiologically present in high concentration in amniotic fluid (diamine oxidase, alpha feto protein, fibronectin, IGFBP-1).
Principle
A monoclonal antibody is immobilized on a nitrocellulose membrane. After collection of vaginal sample, the swab is dipped into an extraction solution. IGFBP-1 from the sample will flow along the membrane and will be captured at the level of the capture antibody. The color signal is generated by gold colloidal particles on which is immobilized a specific IGFBP-1 antibody that will bind to the antigen-antibody complex, thus creating a purple colored line. Presence of purple internal control band in the upper part of the membrane allows validation of a correct procedure.
Packaging
AMNIOQUICK® contains following items to perform the assay:
- Instructions for use
- Sterile Dacron vaginal swab
- Unit dose vial of extraction buffer
- Strips packed in individual pouch containing desiccant bag
- Workstation
Procedure
1) Bring the complete kit and samples to be tested to room temperature prior to testing.
2) Once the strip pouch is opened, it must be used within one hour.
3) Open the unit dose vial and lay it vertically on a flat and horizontal surface.
4) Dip the swab into the unit dose vial and rotate for 10 seconds. Then discard the swab.
5) Dip the strip into the vial with arrows pointing downwards. Gently hit the dipstick on the bottom of the tube to enhance migration. Keep the strip in the tube in vertical position for 10 minutes.
6) Read the result after 10 minutes from the time the strip is dipped in the tube. Do not interpret any Test band appearing 15 minutes after the strip is dipped in the vial.
Storage and Stability
- AMNIOQUICK® test is packed in aluminium pouch with dessicant bag
- Test has to be stored in a dry and cool area at 2-30°C
- Kit has a shelf life of 18 months from the date of manufacturing
- The strips should not be frozen and must be protected from humidity
- Once the pouch is open, the test should be performed within 1 hour maximum
Packaging
0524_K10 … 10 Tests/Kit
0524_K25 … 25 Tests/Kit
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