Status:

COMPLETED

HerpeSelect® Express Rapid Test Study Protocol: Sexually Active Adult Population

Lead Sponsor:

Focus Diagnostics, Inc.

Conditions:

Herpes Simplex Virus 2

Eligibility:

All Genders

18+ years

Brief Summary

This study is designed to compare the performance of the Focus Diagnostics' HerpeSelect® Express, a Herpes Simplex Virus 2 Rapid Test, to a currently marketed device. The intent is to show the rapid t...

Detailed Description

The objective of this study is to establish the performance characteristics of the Focus Diagnostics (Focus) HerpeSelect® Express based on comparison to the Focus Diagnostics' HerpeSelect® 2 ELISA IgG...

Eligibility Criteria

Inclusion

  • Sexually Active Adults - Intercourse in the last twelve months with at least one sexual partner.
  • Subjects must be ≥ 18 years old.
  • No more than 60% of one gender.

Exclusion

  • \<18 years old

Key Trial Info

Start Date :

March 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2008

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT00655434

Start Date

March 1 2008

End Date

May 1 2008

Last Update

January 9 2009

Active Locations (1)

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Providence Clinical Research

Burbank, California, United States, 91505