The Candida albicans Rapid Test Cassette (Vaginal Swab) is a rapid chromatographic immunoassay for the qualitative detection of Candida albicans antigens from vaginal swabs. This test is intended to be used as an aid in the diagnosis of Candida infection.
- Test Cassettes
- Extraction Buffer
- Package Insert
- Extraction Tubes
- Sterile Swabs
- Extraction Tube Tips
Directions for use
Allow the test, specimen swab, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
- Place a clean extraction tube in the designated area of the workstation. Add 8 drops (approx. 450μl) extraction buffer into the tube.
- Put the specimen swab into the tube, vigorously mix the solution by rotating the swab forcefully against the side of the tube for least ten times (while submerged). Best results are obtained when the specimen is vigorously mixed in the solution.
- Allow the swab to soak in the extraction buffer for 1 minute prior to the next step. Squeeze out as much liquid as possible from the swab by pinching the slide of the flexible extraction tube as the swab is removed. At least 1/2 of the extraction buffer solution must remain in the tube for adequate capillary migration to occur.
- Discard the swab in a suitable bio-hazardous waste container, then fit on the extraction tube tip onto the extraction tube.
- Remove the test cassette from its sealed pouch, and place it on a clean and level surface. To obtain the best result, the assay should be performed within one hour.
- Add 3 drops (approx. 100μl) of the extracted specimen from the extraction tube to the specimen well on the test cassette. Please avoid trapping air bubbles in the specimen well and do not drop any solution in the observation window.
- Wait for the colored line(s) to appear. The result should be read at 15 minutes, do not interpret the results after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.
Interpretation of results
POSITIVE: * Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Candida albicans antigen was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Candida albicans antigens present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Candida albicans antigen is not present in the specimen, or is present below the detectable limit of the test.
INVALID: The control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.