MUNUS MEDICAL SELF-DIAGNOSTIC VAGINAL PH TEST MUNUS

Description
Rapid dry chemical method for the semi-quantitative detection of pH in female vaginal swabs as an aid in the diagnosis of bacterial vaginosis.
To determine the pH levels in the vaginal swab sample, a pH paper is used. As soon as the swab with the vaginal sample comes into contact with the pH paper included in the test holder, a color change occurs.
Different pH levels can result in different grades and shades of color, indicating a particular pH level on the color scale for each grade/shade of color. The color obtained on the pH paper after applying the vaginal swab is then compared to the color scale provided with the test.
The result is considered approximately equivalent to the numerical value of the color on the color scale closest to that obtained on the pH paper.

How to use
Sample collection and preparation
Vaginal pH testing can be performed using samples from female vaginal swabs.
Wash your hands before starting the test. Open the package, remove the swab from the pouch and do not touch the head of the swab. Separate the labia, leaving the vagina exposed. Gently insert the head of the swab into the vagina to a depth of about 5 cm and press it lightly on one spot for about 10 seconds.
It is important to leave the swab in the vagina for about 10 seconds in order to properly moisten the head of the swab with vaginal secretions. It is essential for the evaluation of the test that the swab is sufficiently moistened.
Remove the swab from the vagina to perform the test.

Running the test
Allow the test device and swab to reach room temperature (15-30°C) before testing.
Remove the test device from the sealed pouch and use it within one hour. For best results, perform the test immediately after opening the pouch.
Place the test device on a clean, stable surface or hold it with your free hand. Swipe the sample head across the pH reactive area of ​​the test holder at least 5 times, taking care to apply a sufficient amount of secretion.
Read the result immediately, while the measuring area is still wet.
Compare the color of the pH measuring area with the color scale on the pouch and note the value on the scale closest to the color on the test.
After evaluation, dispose of the used test and sample.

Interpretation of results
NORMAL RANGE: Vaginal pH levels between 3.8 and 4.4 are within the normal range. The indicator color is yellow-green.

ABNORMAL RANGE: Vaginal pH levels above 4.4 or below 3.8 are outside the normal/healthy range. When the pH level is above 4.4, the color of the indicator is green-blue, when the pH levels are below 3.8, it is bright yellow.

Warnings
For in vitro self-diagnostic use only. Do not use after the expiry date.
Do not consume food or drink, or smoke in the specimen and test kit handling area.
Used tests must be disposed of according to local regulations.
Humidity and temperature can negatively affect results.
Do not use the test if the package is damaged.
Use each test device only once.
Use only the swab provided with the kit.
Open the swab package only when you are ready to collect the sample.
Do not perform the test within 72 hours of applying vaginal preparations such as contraceptive creams and vaginal medical products (antifungal drugs, vaginal suppositories, creams, gels, douches, etc.).
Do not test within 48 hours of having sexual intercourse.
Do not use the test within 5 days of the end of your menstrual cycle.
Some postmenopausal women may have a high vaginal pH and, as a result, may get an abnormal result on the rapid vaginal pH test even in the absence of a bacterial or parasitic infection.
Some circumstances (menstrual cycle, sexual intercourse, vaginal medical products) can temporarily alter the vaginal pH level and may lead to false results.
Do not shower or wash the affected area immediately before collecting the sample.
Urine can cause a false test result.
Never start any therapy before discussing the test result with a doctor.
Improper sample collection can cause hymen rupture in virgin women.
This test is not intended to detect sexually transmitted diseases, such as HIV, chlamydia, herpes, gonorrhea, or syphilis.

Conservation
Store in the sealed pouch at room temperature or in the refrigerator (2-30 °C). Do not freeze.
The test is stable until the expiration date printed on the package. The test must remain in the sealed package until use. Do not use after the expiration date.
Validity with intact packaging: 24 months.

Format
The kit contains:
- testing device;
- sterile swab;
- package leaflet.

Bibliography
1. Hanna NF, Taylor-Robinson D, Kalodiki-Karamanoli M, Harris J r, McFadyen IR The relationship between vaginal pH and the microbiological status in vaginitis. British Journal of Obstetrics and Gynaecology, 1985, Vol.92 (12), pp.1267-71
2. Nakra Natasha A, Madan Pellett, Buckley Niall etc. Loss of Innate Host Defense Following Unprotected Vaginal Sex. The Journal of infectious diseases, 2016, Vol.213 (5), pp.840-7
3. Roy Subir, Caillouette James C, Faden Joel S, Roy Tapon, Ramos Diana E. Improving appropriate use of antifungal medications: the role of an over-the-counter vaginal pH self-test device. Infectious Diseases in Obstetrics and Gynecology, 2004, Vol.11 (4), pp.209-16
4. Panda Subrat, Das Ananya, Singh Ahanthem Santa, Pala Star. Vaginal pH: A marker for menopause. Journal of mid-life health, 2014, Vol.5 (1), pp.34-7.
5. Maloney C, Oliver M L. Effect of local conjugated estrogens on vaginal pH in elderly women. American Medical Directors Association. Journal, 2003, Vol.2 (2), pp.51-5

Cod. MM-IVPH-504H