SavvyCheck™ Vaginal Yeast Test is a qualitative rapid test for the detection of Candida antigens in vaginal secretions sampled by a swab. The kit is to be used by women who complain of vaginal symptoms. The test is intended to be used by both physicians and patients.
The SavvyCheck™ Vaginal Yeast Test is an immunoassay in which Candida antigens interact during flow along the test strip with anti-Candida specific antibodies conjugated to blue latex particles used as detector. The outcome complex binds during the continuation of the flow to anti-Candida specific antibodies that are immobilized in the detection zone, to create a blue line. The presence of a blue line at the test line position indicates a positive result. The conjugated latex particles interact downstream from the test line with other specific antibodies to create the control line. The presence of a blue line at the control line position indicates proper function of the test.
The SavvyCheck™ Vaginal Yeast Test has been evaluated with specimens obtained from symptomatic and non-symptomatic patients. Culture was used as the reference method. Specimens were considered positive if the culture indicated a positive result. Specimens were considered negative if culture indicated a negative result. The results show that the SavvyCheck™ Vaginal Yeast Test has a high sensitivity and specificity relative to culture results.
þ Easy to use
One step procedure; no need for special skills or instruments compared to culture or microscopy.
· High sensitivity when compared with yeast culture.
· High specificity versus yeast culture. There is no cross-reactivity with other vaginal pathogens, ensuring highly accurate results even when clinical symptoms are equivocal.
· 100% agreement between sampling by physicians and patients.
Results within 20 minutes. No need to wait days for culture results from the laboratory.
The kit has been assessed for reproducibility