- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00655434
HerpeSelect® Express Rapid Test Study Protocol: Sexually Active Adult Population
HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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Burbank, California, United States, 91505
- Providence Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Compare serological status to predicate device
Time Frame: End of study
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End of study
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-001-RT0920G Rev:03/07/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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