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

This study has been completed.
Sponsor:
Information provided by:
Focus Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT00655434
First received: April 2, 2008
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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).


Condition
Herpes Simplex Virus 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population

Resource links provided by NLM:


Further study details as provided by Focus Diagnostics, Inc.:

Primary Outcome Measures:
  • Compare serological status to predicate device [ Time Frame: End of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 400
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community based research clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655434

Locations
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
Sponsors and Collaborators
Focus Diagnostics, Inc.
  More Information

No publications provided

Responsible Party: John Hurrell/Vice President General Manager, Focus Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00655434     History of Changes
Other Study ID Numbers: 06-001-RT0920G Rev:03/07/08
Study First Received: April 2, 2008
Last Updated: January 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Focus Diagnostics, Inc.:
Herpes simplex virus 2
HSV 2
Antibody status to Herpesvirus 2, Human

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014