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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655434
First Posted: April 9, 2008
Last Update Posted: January 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Focus Diagnostics, Inc.
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655434


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

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
First Submitted: April 2, 2008
First Posted: April 9, 2008
Last Update Posted: January 9, 2009
Last Verified: January 2009

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