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Overview
The Amnicator Amniotic Fluid Indicator Test Swabs are a rapid and simple method for detecting prematurely ruptured fetal membranes (PROM) during pregnancy. These swabs are designed for use by qualified healthcare professionals to assess the presence of amniotic fluid in the vagina.
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Composition: Sterile, single-use swab impregnated with a nitrazine yellow pH indicator.
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pH Detection Range: Normal vaginal pH is between 4.5 – 6.0; amniotic fluid typically has a pH of 7.0–7.5.
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Color Change: The swab tip changes color from yellow to blue/green when exposed to amniotic fluid, indicating a pH above 6.5.
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Storage: Room temperature.
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Shelf Life: Approximately 2 years.
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Packaging: 10 swabs per box.
Clinical Use:
To perform the test:
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Preparation: Ensure the patient is in a comfortable position.
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Speculum Insertion: Gently insert a sterile speculum to visualize the cervix.
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Swab Application: Carefully insert the Amnicator swab into the vagina and sample any fluid present at the external cervical os or in the posterior fornix.
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Observation: Withdraw the swab and watch the color change.
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Interpretation: A color change to blue/green indicates the presence of amniotic fluid.
Important Safety Information:
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Contraindications: Not for use in neonates.
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Warnings:
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Use with caution in patients with known allergies to nitrazine or other components of the swab.
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False positives may occur if the swab comes into contact with semen or blood.
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Storage: Store at room temperature, away from direct sunlight.
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Expiration: Do not use past the expiration date indicated on the packaging.
Medical Devices Regulations (SOR/98-282).
Manufacturer: AmniSure International
