Amniocheck

Ref. 100088-5

Amniotic leak Self-Test detector

AMNIOTIC FLUID LEAKS

Amniotic fluid is a substance composed by water (more than 90%) and mineral salts, as well as other substances necessary for the growth of the fetus. The main functions of the amniotic fluid are nutrition, thermal regulation and protection of the unborn child from trauma, sounds and noises coming from the outside.
From the 38th week of pregnancy the amniotic fluid will decrease, indicating that the fetus is preparing for birth.

The risk of amniotic fluid leak is greater during the 48 hours following the amniocentesis test or in case of previous episodes of premature rupture of amniochorial membranes (PROM). Unjustified leaks, even in the absence of the aforementioned risk factors, can be linked to PROM and PPROM.

WHO IS THIS TEST FOR?

AMNIOCHECK can be used by anyone who wants to promptly check for any leaks of amniotic fluid.

The use of AMNIOCHECK is recommended for both pregnant women who want to monitor any sensations of wetness, especially if at risk of PROM and PPROM; but also, to gynecological centers for the screening of possible leaks of amniotic fluid, especially if discontinuous.

TECH SPECS

AMNIOCHECK is an in vitro self-test that allows you to detect any leaks of amniotic fluid if the physician believes that the risk of leaks of this type is higher than normal.
The absorbent device changes color if it comes into contact with a fluid characterized by a pH value greater than or equal to 6.5. The amniotic fluid usually has a pH value greater than 6.5.

Specificity	96.9%
Sensitivity	97.1%
PPV	96.1%
NPV	97.67%

CONTENT

5 panty-liner tests
instructions for use

USE PROCEDURE

Take AMNIOCHECK out of the sealed pouch and check for a light-yellow stripe;
Adhere the device to your underwear so that the yellow stripe is in contact with your vagina;
Wear the panty-liner until you feel a wet sensation – in any case no more than 12 hours;
If AMNIOCHECK is still completely yellow but you feel a wet sensation, replace the device with a new one.

RESULTS INTERPRETATION

Negative	the device does not change color or it turns yellow once the 15 minutes for reading the result have elapsed.
Probable leak of amniotic fluid	there is a change in color, complete or partial, which turns towards blue or green, of any intensity, size, shape and position.

VIDEO INSTRUCTIONS

BIBLIOGRAPHY

1. Bornstein J, Geva A, Salt I, Fait V, Schoenfeld A, Shoham HK, Sobel J. Nonintrusive diagnosis of premature ruptured amniotic membranes using a novel polymer. Am J Perinatol. 2006 Aug; 23(6):351-4.
2. Bornstein J, Ohel G, Sorokin Y, Reape KZ, Shnaider O, Kessary-Shoham H, Ophir E. Effectiveness of a novel home-based testing device for the detection of rupture of membranes. Am J Perinatol. 2009 Jan;26(1):45-50.