A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
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About
This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.
Full description
This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).
Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.
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Inclusion criteria
- At least 15 years of age at time of enrollment
- Ability to provide written informed consent
Exclusion criteria
- Currently menstruating or bleeding
- Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days
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Data sourced from clinicaltrials.gov
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