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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial 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 (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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00682851
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date July 2008
Completion date April 2009
View Details
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