NCT00682851

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 519 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Bacterial Vaginosis
• Urogenital Infection by Trichomonas Vaginalis

Interventions

Type	Name	Description
DEVICE	OSOM Trichomonas Rapid Test	Rapid test run using vaginal discharge collected via a cotton swab
DEVICE	OSOM BVBlue Test	Rapid test run using vaginal discharge collected using a cotton swab

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-05-22
• Last updated: 2016-09-22
• Results posted: 2011-08-08

Locations

1 site across 1 country: United States