SCREEN CHECK TEST
Screen Test Candida
Description
Qualitative rapid self-test able to detect the presence of Candida antigens in samples of vaginal secretions collected with a swab.
The test is based on the immunochromatographic method. The sample collected with the swab is added to the sample pad through the cap containing the dilution buffer. From here the sample migrates towards the conjugate pad, releasing anti-Candida antibodies conjugated with blue-coloured latex particles. The Candida antigen-antibody conjugate complex formed continues to move until it reaches the nitrocellulose membrane strip. The complex is then captured on the support membrane by immobilised anti-Candida antibodies, generating a signal line.
If Candida antigens are present in the swab sample, a biological reaction will take place and the result will be positive. A blue line will appear in the test line area (T) on the membrane.
The test includes a built-in control system, represented by the control line (C). The control line confirms that the test has been performed correctly.
Directions for use
Leave the test cassette at room temperature (between 15 °C and 27 °C) before carrying out the procedure.
Open the test kit only when you are ready to carry out the procedure. Do not use the test if the pouch is damaged. Keep a clock/timer to hand.
Make sure the surface on which the procedure will be carried out is clean. Wash your hands. The test can be performed at any time of day.
Remove the device from the sealed pouch and place it horizontally on a flat surface. Hold the device steady with one hand. With the other hand, gently remove the aluminium seal from the purple cap. The purple cap contains a liquid.
Remove the swab from its wrapper. Insert the swab about 2 cm into the vagina and rotate for 20 seconds. Gently withdraw the swab.
Rotate the swab in the liquid in the purple cap for 20 seconds. Gently withdraw the swab, pressing it against the inside wall of the purple cap. Throw the swab away.
Hold the device steady with one hand. Turn the purple cap anticlockwise as far as it will go, then turn it in the opposite direction back to the starting point. Repeat this step two more times. At the end point, the notches on the purple cap must be aligned with the recess on the white base.
Read the results after 10 minutes.
Interpreting the results
POSITIVE: a blue line appears at the control line (C) and a further blue line appears at the test line (T).
The test result indicates that Candida antigens are present in the vaginal secretions. Consult a doctor to confirm the result and start treatment.
NEGATIVE: only a blue line appears at the control line (C) and no blue line appears at the test line (T).
The test result indicates that Candida antigens are not present in the vaginal secretions. If symptoms or discomfort persist, consult a doctor.
INVALID: if neither line appears or only the test line (T) appears, the test result cannot be interpreted. A new test must be performed, carefully following the instructions.
Warnings
For in vitro diagnostic use only.
Do not insert the device into the body.
The test is not reusable.
The test works only if the instructions are followed carefully.
A negative test result does not rule out other infections. Consult your doctor.
The test should not be used during menstruation.
Suitable only for women aged 18 and over.
Do not use during pregnancy.
Do not use the test within 7 days of taking medicines for vaginal infections.
Do not use the test within 24 hours of using creams, gels, foams, douches or other intimate hygiene products.
Do not use after the expiry date printed on the aluminium pouch.
Keep out of the reach of children.
Dispose of the device and swab with normal household waste.
Do not use the swab if it falls on the floor.
Do not use the test components if they are broken.
Do not use if liquid has leaked from the cap. The amount of liquid inside the cap is essential for the test to work correctly.
Do not turn the cap before removing the seal or inserting the swab. Turning the top of the device has an irreversible effect, as the test will no longer be valid.
Storage
Store in a dry place at room temperature (between 2 °C and 30 °C).
Shelf life in intact packaging: 24 months.
Size
The kit contains:
- 1 test cassette;
- 1 sterile swab;
- 1 instruction leaflet;
- 1 translated information sheet.
