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Product Information
Statistical Measures of the Sensitivity, Specificity and Overall Agreement of the Test kit Compared to Control Methods.
The FDA clinical trials compared the sensitivity and the specificity levels in comparison with reference methods. Detailed explanations are provided on the package insert.
Vaginitis |
Sensitivity |
Specificity |
Positive Predictive Value |
Negative Predictive Value |
Overall Agreement |
Prevalence in trial population |
Bacterial Vaginitis |
89.4% |
78.6% |
68.9% |
93.3% |
82.3%. |
31% |
Chlamydia Vaginitis |
92.0% |
92.0% |
92.0% |
99.3% |
98.7%. |
8% |
Trichomonal Vaginitis |
84.7% |
89.3% |
75.8% |
93.7% |
88.0% |
24% |
Yeast Vaginitis |
91.4% |
83.1% |
80.1% |
92.9% |
86.7%. |
39% |
Rapid, Screening test on vaginal smear
The Vaginitis test kit is an FDA approved, CE marked screening device for use in the detection of the major forms of vaginitis in vaginal fluid specimens.
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The test kit is primarily a screening tool, and any positive result should always be referred to a clinician for further evaluation and for treatment.
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The test kit has many advantages which make it ideal for the POC and Doctor’s office use: it is easy to get sample, easy to perform on site, and quick (under 10 min.) to check color changes.
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The following parameters are tested: pH, Gardnerella, Nitrites, Blood, Protein and Leukocytes.
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These parameters are associated with a specific vaginal status - the combination of the various results and user friendly tables allow an easy understanding of the presence of vaginosis or vaginitis.