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

Herpes Simplex Virus 2 Clinical Trial

Official title:

HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655434
• Other study ID #: 06-001-RT0920G Rev:03/07/08
• Status: Completed
• Phase: N/A
• First received: April 2, 2008
• Last updated: January 8, 2009
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: January 2009
• Source: Focus Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex Virus 2

Locations

Country	Name	City	State
United States	Providence Clinical Research	Burbank	California

Sponsors (1)

Lead Sponsor	Collaborator
Focus Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare serological status to predicate device		End of study	No