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

NCT ID: NCT00655434

Last Updated: 2009-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-05-31

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 test device is comparable to the currently marketed device. HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (capillary).

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 (K021486). The Focus HerpeSelect® 2 ELISA IgG device is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. Positive samples in either the HerpeSelect® 2 ELISA IgG or HerpeSelect® Express will be tested in the HerpeSelect® Immunoblot (K000238).

This external study along with in-house analytical studies will demonstrate the efficacy of the HerpeSelect® Express Rapid Test device as an aid in screening for pregnant women or sexually active adults as in the presumptive diagnosis of HSV-2 infection for point-of-care testing sites as well as hospital/clinics and reference laboratories. Independent sites in the Southeastern, Western, Eastern, and Pacific Northwestern U.S. will test subjects with the HerpeSelect® Express Rapid Test. Sera from those patients will be tested at Focus Diagnostics Reference Laboratory in the HerpeSelect® 2 ELISA IgG. Discrepants between HerpeSelect® Express Rapid Test and HerpeSelect® 2 ELISA IgG may be tested in the HerpeSelect® Immunoblot IgG assay.

Test subjects will be from three patient populations: 375 sexually active adults, 375 pregnant women, and 100 low prevalence adults. Two samples types will be collected from each subject: capillary whole blood and serum. These samples types will be tested with both the HerpeSelect® Express Rapid Test and HerpeSelect® 2 ELISA IgG.

Conditions

Herpes Simplex Virus 2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

SAA

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• <18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Focus Diagnostics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Focus Diagnostics, Inc.

Locations

Providence Clinical Research

Burbank, California, United States

Countries

United States

Other Identifiers

06-001-RT0920G Rev:03/07/08

Identifier Type: -

Identifier Source: org_study_id