Candida Albicans Rapid Test with Vaginal Swab Cassette Device Kit

INTENDED USE
The Candida albicans Rapid Test (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.

SAMPLE COLLECTION
It is recommended to use the swab supplied by the kits manufacture.
• Insert the swab into the inside of the vagina, and rotate for 10 seconds. Pull the swab out carefully.
• Do not place the swab in any transport device containing medium since transport medium interferes with the assay and viability of the organisms is not required for the assay. Put the swab to the extraction tube, if the test is to be performed immediately. If immediate testing is not possible, the patient specimen should be placed in a dry transport tube for storage or transport. The swabs may be stored for 24 hours at room temperature (15-30ºC) or 1 week at 4ºC or no more than 6 months at -20ºC. All specimens should be allowed to reach a room temperature of 15-30ºCbefore testing.
• Do not use 0.9% sodium chloride to treat swab before collecting specimen.
• The solution remaining in the test tube used for the wet mount may also be used as the specimen for the Candida albicans test. To use this specimen type, add 3 drops of the solution
to the specimen well directly. These saline specimens may be held at room temperature for on longer than 24 hours. These specimens may also be stored at 4ºC for up to 1 week or -20ºC for 6 months.
• To run a culture as well as the Candida albicans Rapid Test. Separate swabs must be used, because the buffer will influence Candida organisms.

OPERATION

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Place a clean extraction tube in the designated area of the workstation. Add entire 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 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 colored bands appear on the membrane. 
Negative (-)
Only one colored band appears, in the control region (C). 
Invalid
Control band fails to appear. 

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