AMNICATOR® PMR TEST

Amnicator® is a rapid and simple method for detecting ruptured amniotic membranes. Amnicators® are individually wrapped sterile swabs impregnated with a sensitive pH indicator, Nitrazine yellow. The principle of the Amnicator® test is that normal vaginal pH at term ranges between 4.5-6.0 and amniotic fluid is usually 7.0-7.5. By means of a simple pH color change of the Nitrazine yellow, which has a sharp end point, (6.4-6.8), exactly in the desired pH range, the midwife or obstetrician can accurately detect the presence of amniotic fluid. Amnicator® will reliably distinguish neutral or slightly alkaline amniotic fluid from the acidic cervical and vaginal mucus or urine.

Using a sterile speculum an Amnicator®is introduced into the vagina and any fluid coming from the cervix or pooled in the posterior vaginal fornix is sampled. The Amnicator® is then simply withdrawn and examined for a color change. Leakage or even a small amount of fluid is sufficient to change the nitrazine yellow indicator. The Amnicator® test is far quicker and simpler to perform than resorting to the microscopic examination of escaping fluid, detecting the presence of protein or using orally administered dyes to stain urine, to distinguish amniotic fluid from normal secretions and urine.

Reagents and material

• PMR test is a sterile device packaged in an individual plastic pouch.
• Each kit contains 50 or 100 swabs.

Storage and stability

• When stored at the room temperature and protected from light the devices are stable until the expiry date stated on the label.

Performance

• A clinical study was performed on 114 samples of vaginal secretions provided by 104 patients.
• The PMR Test was compared with the clinical diagnosis and DAO method (Enzymatic activity of DIAmine Oxidase present at high concentration in amniotic fluid).
• The sensitivity of PMR test is significantly superior to that obtained with DAO quantitative method.

Material required but not provided

• Speculum