Vaginal ph test - self-diagnostic kit for self-analysis

Product Description

Rapid vaginal pH test.

Indications

The Vaginal pH Test by Sofarmapiù is a rapid test for the semi-quantitative detection of pH in female vaginal swabs, as an aid in the diagnosis of bacterial vaginosis.

Directions for use

Sample collection and preparation

• The test can be used This test can be performed using female vaginal swab specimens.
• Wash your hands before starting the test.
• Open the package, remove the swab from the pouch and do not touch the swab head (polyester head).
• Separate the labia, leaving the vagina exposed.
• Gently insert the swab head into the vagina and press it lightly on one spot for about 10 seconds, once a length of about 5 cm has been inserted (about the length of an AA battery).
• It is important to leave the swab in the vagina for about 10 seconds in order to properly moisten the swab head with vaginal secretions.
• It is essential for the test evaluation that the swab is sufficiently moistened.
• Remove the swab from the vagina to perform the test.

Performing the test

• Wait for Allow the test and swab to reach room temperature (15-30°C) before testing.
• Remove the test cassette from the sealed pouch and use it within one hour.
• For best results, perform the test immediately after opening the pouch.
• Place the test cassette on a clean, stable surface or hold it with your free hand.
• Rub the sample head on the pH reactive area of ​​the test cassette 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 closest scale value. next to the color on the test.
• After evaluation, discard the used test and sample.

Reading Results

Results are obtained by visually comparing the pH measuring zone to the color scale on the package.

• 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 indicator color is green-blue; when pH levels are below 3.8, it is bright yellow.

Warnings

For in vitro self-testing use only. Do not use after the expiration date. Do not consume food, drink, or smoke in the area where samples and kits are handled. Used tests must be disposed of according to local regulations. Humidity and temperature may adversely affect results. Do not use the test if the packaging is damaged. Use each test tray only once. Use only the swab provided with the kit. Open the swab packaging only when collecting the sample. Do not use this test within 72 hours of applying vaginal preparations such as birth control creams and vaginal medical products (antifungal medications, vaginal suppositories, creams, gels, douches, etc.). Do not use this test within 48 hours of sexual intercourse. Do not use this test within 5 days of the end of your menstrual cycle. Some menopausal women may have a high vaginal pH and, as a result, may obtain an abnormal result with the rapid vaginal pH test even in the absence of a bacterial or parasitic infection. Certain circumstances (menstrual cycle, sexual intercourse, vaginal medications) can temporarily alter the vaginal pH level and may lead to false results. Therefore, it is necessary to follow precautions when performing the test. Do not shower or wash the affected area immediately before collecting the sample. Please note that urine can cause a false analytical result. Never start any treatment before discussing the test result with a doctor. Improper use can cause hymen rupture in virgin women, as occurs with the use of tampons. This is not a test for sexually transmitted diseases such as HIV, chlamydia, herpes, gonorrhea, or syphilis.

Storage

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 sealed pouch. The test must remain in the sealed pouch until use. Shelf life if packaged intact: 24 months.

Format

The kit contains: test cassette; sterile swab; package insert.