INTENDED USE

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.

SUMMARY

Candida albicans is an opportunistic pathogenicyeast1that is a common member of the human gut flora. It does not proliferate outside the human body.2 It is detected in the gastrointestinal tract and mouth in 40-60% of healthy adults.3,4It is usually a commensal organism, but can become pathogenicin immune compromised individuals under a variety of conditions.4,5It is one of the few species of the Candida genus that causes the human infection candidiasis, which results from an overgrowth of the fungus.4,5Candidiasis is for example often observed in HIV-infected patients.6C.albicansis the most common fungal species isolated from biofilms either formed on (permanent) implanted medical devices or on humantissue.7,8 C.albicans, together with C.tropicalis, C.parapsilosis and C.glabrata, is responsible for 50–90% of all cases of candidiasis in humans.5,9,10 A mortality rate of 40% has been reported for patients with systemic candidiasis due toC.albicans.11Estimates 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 through visual interpretation of color 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 colored particles impregnated onto the label pad of the test unit. 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 colored line will form at the test region of the membrane. The presence of this colored line indicates a positive result, while its absence indicates a negative result. The appearance of a colored line at the control region serves as a procedural control, indicating that proper volume of specimen has been added and membrane wicking has occurred.