PerioMonitor™ is a rapid test intended for semi-quantitative detection of leukocyte esterase in oral rinse fluid collected from individuals of 18 years old and older. Leukocyte esterase is secreted by leukocytes such as neutrophils that are produced during inflammatory conditions such as gingivitis. The reactive zone of the PerioMonitor™ test strip is coated with an indoxyl ester that forms indoxyl by an hydrolysis reaction catalyzed by leukocyte esterase. The indoxyl formed in the reaction reacts with a diazonium salt to produce a purple color.

This test is intended for prescription use at point-of-care sites by health care professionals. PerioMonitor™ is indicated to aid in the detection of gingivitis.

The PerioMonitor™ test kit provides a rapid and convenient method for indicating the presence of leukocyte esterase in the mouth.

A symptom of periodontal diseases such as gingivitis causes an increase of white blood cells in the mouth. A diagnosis of gingivitis is made by a combination of clinical symptoms and radiographic/laboratory findings. The presence of the following conditions are commonly used for diagnosis of periodontal diseases1:

1. Symptoms and signs of periodontal inflammation, such as gingival swelling, spontaneous gingival bleeding, bleeding on probing, bleeding on brushing.

2. Demonstration of ongoing gum and bone loss from around the teeth as determined clinically by a clinical periodontal exam and dental radiographs.

Leukocyte esterase concentration in oral rinse fluids increases when neutrophil counts increase in response to periodontal diseases. PerioMonitor ™ is designed to give a semi- quantitative indication of the level of leukocyte esterase present in oral rinse fluid collected from the patient, which has been shown to correlate with gingivitis. 

Specimen Collection and Preparation

1. The patient pre-rinses his/her mouth for 15 seconds with tap water.

2. After waiting another 2 minutes, the patient rinses again his/her mouth, this time with the provided rinse fluid for 30 seconds. The entire volume (10 mL) should be used for rinse.

3. The patient expectorates/spits it back into the disposable cup provided with the kit.

Testing of the oral rinse fluid should be done within 10 minutes of collection at room temperature (15°-30°C / 59°-86°F).

Directions for Test (Dip Method)

1. Remove one PerioMonitor™ Test Strip from the bottle and immediately replace the cap. Never touch the indicator pad with your hands. If such an event occurs, use another test strip.

2. Completely immerse the indicator pad of the test strip into the oral rinse fluid, remove it after one (1) second, and start a timer.

3. Place the PerioMonitor™ test strip (indicator pad facing up) on a flat, clean surface. One (1) minute after removing the test strip from the sample, compare the color of the indicator pad to the color chart provided with the kit. Do not read the result after 90 seconds (1.5 minutes). If such an event occurs, test another test strip.

NOTE: Do not immerse the indicator pad into the oral rinse fluid for more than 1 second as reagents may be washed out, possibly causing a false “Negative” result. 

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References

1. Quick Reference Guide

2. Health Canada - Informations for Use