Candida Infection Diagnostic with High Sensitivity and Specificity

Vulvovaginal candidiasis (VVC) is a common condition in women worldwide, with more than 75% of women experiencing an infection once in their lifetime and 40-45% having two infections or more. On rare occasions, men may also get genital candidiasis. VVC occurs more frequently and more severely in diabetics, pregnant women, and those with weakened immune systems.

Most candidiasis patients are infected with Candida albicans, but the number of non-Candida albicans infections has grown steadily in recent years. Importantly, yeast infections caused by some non-albicans species are resistant to the azole drugs typically prescribed for C. albicans infections, resulting in persistent and recurrent non-albicans yeast infections. The rise in Candida species infections and the differences in effective therapeutic strategies highlight the need for a sensitive, rapid, and species-specific method to diagnose vulvovaginal candidiasis and to guide appropriate treatment.

A Centers for Disease Control and Prevention (CDC) research team headed by Dr. Christine J. Morrison developed a method to detect the presence of and identify Candida species with high sensitivity and specificity. This breakthrough CDC technology was licensed to Quest Diagnostics, Inc., the largest U.S. provider of medical laboratory tests. Quest Diagnostics developed the SureSwab® Candidiasis test, which uses a single swab to obtain a vulvovaginal specimen, followed by DNA extraction, real-time polymerase chain reaction (PCR) amplification, and the identification of Candida species DNA sequences. This gynecological test provides women with a rapid and specific diagnosis of a vaginal yeast infection for the major Candida species to facilitate timely and appropriate treatment. When combined with other Quest Diagnostics technology in a panel, this test detects VVC infections while also ruling out other genital infections.

This effort led to a successfully commercialized product that has an incredible impact on women's health. By diagnosing patients more quickly and precisely, women suffering from VVC can receive prompt treatment and not succumb to complications such as severe infection (or direct extension to the urinary tract); recurrence; non-albicans candidiasis; or added consequences for diabetic, pregnant or immunosuppressed women who have more frequent and serious infections. Additionally, this has spurred more inventions for diagnosing other fungal infections and greatly increased the body of available tests for a variety of fungal infections, aiding in the surveillance and treatment of fungal diseases.

Contact: Lisa Marianni, (404) 639-0377, lmarianni@cdc.gov

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Southeast