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

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ClinicalTrials.gov Identifier: NCT00655434
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : January 9, 2009
Sponsor:
Information provided by:
Focus Diagnostics, Inc.

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).

Condition or disease
Herpes Simplex Virus 2

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.


Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population
Study Start Date : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Compare serological status to predicate device [ Time Frame: End of study ]

Biospecimen Retention:   Samples With DNA
Serum


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

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.

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 Posted: April 9, 2008    Key Record Dates
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