A novel rapid vaginal yeast infection test

Abstract number: 1134_03_254

Greenberg Z., Illouz M., Margalit R., Kopelowitz J., Shaposhnikov M., Babai O., Chertof B., Lee M.

Objectives:  

Vulvovaginalcandidiasis (VVC) is thought to be one of the most common causes of vaginal infections. Currently, the diagnosis of VVC relies on microscopy, which has been shown to have a limited sensitivity and may be subject to significant operator-error. Yeast cultures, the gold standard for diagnosing VVC, are expensive, underutilized, and may take a week to give positive results. A rapid test for vaginal yeast would greatly aid in the diagnosis of VVC, but no such test currently exists. The need for a rapid test is further emphasized in view of availability of over-the-counter anti-fungal medications. The use of a home-test will avoid misuse of medications and may reduce health-care costs.

Methods:  

Savyon Diagnostics has recently finalized the development of a diagnostic kit for rapid detection of vaginal Candida infections. The test is intended to be used as a laboratory, point of care and over-the-counter test, meaning that vaginal secretion samples may be obtained through either patient or physician sampling. The kit is composed of a sampling swab and a unique detection device, which houses a test strip, functioning as a lateral flow immuno-chromatographic-based test. The novel device enables extraction of the Candida antigens from the sampling swab, in-device dilution, transfer of the sample liquid into the detection strip via an innovative mechanism, and providing clear results in short time. All in two steps.

Results:  

The test provides clear, reliable and unchangeable results within 5 minutes. It detects Candidaalbicans, which is the most abundant species, but also others like C. glabrata, the secondary in abundance. Sensitivity and specificity have been shown to be comparable to the results of yeast culture taken as a reference method. The results are also in accordance with clinical symptoms. Precision tests further validate the test quality. The test kit has been proven to be user friendly, as shown by the similarity between the results obtained by physician sampling vs. patient self-sampling. Surveys have shown high contentment of potential users in regard to the device operation as well as its innovative shape.

Conclusions:  

A novel kit including a unique device has been developed to fill the widely desired need for a rapid and reliable diagnosis of vaginal yeast infections. The kit may be used either at home or in the clinic, may avoid misuse of antifungal drugs, and save health-care costs.