The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM.
- Sterile for patient safety
- Rapid, safe and easy to use
- Test results in 15 seconds
- No speculum required
- Easy peel opening
- Up to 3-years shelf life
- Canadian manufactured product
- Easy to QC with available buffers to match colour interpretation card
- Education PowerPoint available for staff training to meet POC requirements Click here for documents
How Does AmnioTest™ Work?
The pH of the vagina is normally acidic. Rupture of fetal membranes can result in small amounts of amniotic fluid leaking into the upper vagina. Amniotic fluid has a neutral pH. Thus, the presence of amniotic fluid elevates the pH of the upper vagina. AmnioTest™ is a sterile swab impregnated with nitrazine yellow dye that when brought into contact with the upper vagina will absorb fluid and develops a colour to correlate with the pH of the absorbed fluid ranging from pH 5.0 to pH 7.5. A possible ruptured membrane is indicated if the swab has a pH of 6.5 to pH 7.5 turning the swab dark green to navy blue. A colour interpretation card is included with each box of AmnioTest™. The colour squares on the card are only examples always use the colour description found in the IFU in combination with the colour squares as part of your interpretation. For example, pH 6.0 (indicative of an intact membrane) is an olive green while pH 6.5 (indicative of a possible ruptured membrane) is a dark green.
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Note: For detailed steps, please refer to Instructions For Use in Available Documents
|PL. 901-20||AmnioTest™||20 Swabs|
|PL.902||AmnioTest™ Colour Interpretation Cards||50 Cards|
|PL.910||Buffer Solution pH 5.0||2.0 ml|
|PL.911||Buffer Solution pH 5.5||2.0 ml|
|PL.912||Buffer Solution pH 6.0||2.0 ml|
|PL.913||Buffer Solution pH 6.5||2.0 ml|
|PL.914||Buffer Solution pH 7.0||2.0 ml|
|PL.915||Buffer Solution pH 7.5||2.0 ml|
Product Brochure Français AmnioTest™ Test Procedure Education
AmnioTest™ Test Procedure Education Français
AmnioTest™ Quality Control Sheet Safety Data Sheet AmnioTest™ (PL.901) Canadian/U.S.
Safety Data Sheet AmnioTest™ (PL.901) Canadian/U.S. Français Safety Data Sheet Buffer Solutions (PL.910 to PL.915) Canadian/U.S.
Safety Data Sheet Buffer Solutions (PL.910 to PL.915) Canadian/U.S. Français