Accu-Tell® Vaginal PH Rapid Test Panel (Vaginal Discharge)
|Product Name||Specimen||Catalog No.||Quantity per box||Certificate|
|Vaginal pH Panel||Swab||ABT-FT-B227||40T/20T|
Detection for: Vaginal pH level;
Reading time: Immediately after removing the vaginal applicators;
Relative Sensitivity: 100 %;
Relative Specificity: 86.4 %;
An acidic vaginal pH value of 3.8 to 4.5 is a basic requirement for the optimal functioning of the body’s own system of protecting the vagina. This system can effectively avoid colonization by pathogenic germs and the occurrence of vaginal infections. The most important and most natural protection against vaginal problems is therefore a healthy vaginal flora. There are many factors that regulate the composition and dynamics of the vaginal microbial ecosystem and that maintain the natural protective functions of the vagina.
ACCU-TELL® Vaginal PH Rapid Test Panel (Vaginal Discharge) is a reliable, hygienic, pain-free method of determining the vaginal pH level.
Allow the test reach room temperature (15-30°C) prior to testing.
1. Wash your hands before starting the test.
2. Open the package, remove a test and open the foil. Only touch the applicator in the round handle area.
3. Hold the applicator in the handle area between your thumb and index finger, as shown in diagram 1.The thumb should always be kept on the side of the vaginal applicators opposite to the pH measurement zone. If you use the vaginal applicator in this way, each test will be performed correctly.
4. Avoid the pH measurement zone coming into contact with other liquids.
5. Sit with your knees spread or with one foot on the toilet seat or other firm surface.
6. Now use your free hand to gently spread the vaginal opening, carefully separating the outer labia.
7. Insert the vaginal applicator gently into the vagina, in the same way that you would use a tampon, see diagram 2. (approx. 1 to 3 cm into the vagina – but not further than the round handle area). Inserting the vaginal applicators is completely pain free.
8. Now press the inserted tube against the back wall of the vagina (with very light pressure) for approx. 10 seconds (pushing towards the rectum), so that the pH measurement zone becomes well moistened. Sufficient moisture is very important for the test evaluation.
9. Now carefully remove the vaginal applicator from the vagina.
10. Read the result immediately after removing the vaginal applicators, while the measurement zone is still damp. Compare the color in the pH measurement zone with the color scale and note the value on the color scale that is most similar to the pH level you have measured. After evaluation, dispose of the used applicator.
The measuring range of ACCU-TELL® Vaginal PH Rapid Test Panel (Vaginal Discharge) includes pH values from 4.0 to 7.0.
Sensitivity and specificity The product was tested in comparison with a pH meter. The sensitivity was 100 % and the specificity 86.4 %.
Fitness for purpose:
a lay study was conducted in two parts.
In the first part, involving 56 participants, only the pH value of two blind samples was determined.
In the second part, involving 20 participants, the participants’ own vaginal pH value was determined in addition to the blind samples. The aims of the study were to test whether the instructions were clearly understandable, whether the test could be performed without problems and handled easily, and whether non-professionals are able to determine pH values semiquantitatively.
The result was that the precise pH value of the blind samples was correctly determined in 96 and 97per cent of cases, respectively. The deviations from the absolute pH value were generally one levelhigher or lower. In all cases the pH range was correctly determined.
Medicinal products were tested as potential interference factors; a cross-reaction occurred with haemoglobin.
1. ACCU-TELL® Vaginal PH Rapid Test Panel (Vaginal Discharge) is for in vitro diagnostic use only.
2. ACCU-TELL® Vaginal PH Rapid Test Panel (Vaginal Discharge) will only indicate the vaginal pH level.
3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
4. Other clinically available tests are required if questionable results are obtained.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.