A rapid test for the qualitative detection of Candida albicans antigen from vaginal swabs.

INTENDED USE

This test is intended to be used as an aid in the diagnosis of Candida infection. The Candida albicans Rapid Test Cassette (Vaginal Swab) is a rapid chromatographic immunoassay for the qualitative detection of Candida albicans antigens from vaginal swabs.

SUMMARY

The microorganism Candida albicans is an opportunistic pathogenic yeast. It is a common member of the human gut flora. It does not proliferate outside the human body. That is detected in the gastrointestinal tract and mouth in 40-60% of healthy adults. Candida albicans is usually a commensal organism, but can become pathogenic in immunocompromised individuals under a variety of conditions. Albicans is one of the few species of the Candida genus that causes the human infection candidiasis, which results from an overgrowth of the fungus. Candidiasis is for example, often observed in HIV-infected patients. C. albicans is the most common fungal species isolated from biofilms either formed on (permanent) implanted medical devices or on human tissue. C. albicans, together with C. tropicalis, C. parapsilosis and C. glabrata, are responsible for 50–90% of all cases of candidiasis in humans. A mortality rate of 40% has been reported for patients with systemic candidiasis due to C. albicans. Estimates range from 2800 to 11200 deaths caused annually in the USA due to C. albicans causes candidiasis.

PRINCIPLE

The Candida albicans Rapid Test Cassette (Vaginal Swab) is a qualitative, membrane based immunoassay for the detection of Candida albicans antigens. This is done through a visual interpretation of colour development on the internal strip. Anti-Candida albicans antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-Candida albicans antibodies conjugated to coloured particles impregnated onto the label pad of the test.

The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is sufficient Candida albicans antigens in the specimen, a coloured line will form at the test region of the membrane. The presence of this coloured line indicates a positive result, while its absence indicates a negative result.

The appearance of a coloured line at the control region serves as a procedural control, indicating that proper volume of specimen has been added and membrane wicking has occurred.

DIRECTIONS FOR USE

Allow the test, specimen swab, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Place a clean extraction tube in the designated area of the workstation. Add 8 drops (approx. 450μl) extraction buffer into the tube.

2. 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.

3. 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.

4. Discard the swab in a suitable bio-hazardous waste container, then fit on the extraction tube tip onto the extraction tube.

5. Remove the test cassette from its sealed pouch, and place it on a clean and level surface. To obtain a best result, the assay should be performed within one hour.

6. Add 3 drops (approx. 100μl) of 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 observation window.

7. Wait for the coloured 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.

For the full instructions on how to use this test kit please click here.

PRECAUTIONS

1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

5. The used test should be discarded according to local regulations.

6. Humidity and temperature can adversely affect results.

7. Do not exchange or mix buffer and test cassettes from kits of different lots.

8. Be sure to add sufficient extracted specimen to the cassette’s specimen well. Invalid result may occur if inadequate extracted specimen is added.