Candida albicans Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Candida albicans antigen in female cervical swab and male urethral swab specimen. The test results are intended to aid in the diagnosis of Candida albicans infection in people.
MATERIALS
Materials Provided
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· Individually packed test devices |
· Dropper tips |
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· Buffer |
· Workstation |
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· Disposable sampling swabs (Female Cervical) |
· Extraction Tubes |
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· Package insert |
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Materials Required but Not provided |
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· Sterile Male Urethral Swabs |
· Timer |
TEST PROCEDURE
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
- 1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
- 2. Extract the Candida albicansantigen according to the specimen type.
- For Female Cervical or Male Urethral Swab Specimen:
- Hold the bufferbottle vertically and add 10 drops of buffer (approx. 300μl) to the extraction tube. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
- Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.
- 3. Place the test cassette on a clean and level surface. Add 4 full drops of the extracted solution (approx. 100μl) to each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
- 4. Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.
Note: It is recommended to use the buffer within 6 months after opening the vial.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
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LIMITATIONS OF THE TEST
- 1. The Candida albicansAntigen Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human Candida albicans infection.
- 2. The test result should be used only to evaluate with patient with signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
- 3. As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.
4. As all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
