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Sponsored by: |
Focus Diagnostics, Inc. |
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Information provided by: | Focus Diagnostics, Inc. |
ClinicalTrials.gov Identifier: | NCT00655434 |
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 |
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Herpes Simplex Virus 2 |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population |
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 |
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Community based research clinic
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Focus Diagnostics, Inc. ( John Hurrell/Vice President General Manager ) |
Study ID Numbers: | 06-001-RT0920G Rev:03/07/08 |
Study First Received: | April 2, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00655434 |
Health Authority: | United States: Institutional Review Board |
Herpes simplex virus 2 HSV 2 Antibody status to Herpesvirus 2, Human |
Virus Diseases Herpes Simplex Antibodies Skin Diseases, Infectious |
Skin Diseases DNA Virus Infections Immunoglobulins Herpesviridae Infections |
Skin Diseases, Viral |