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
|Condition or disease|
|Herpes Simplex Virus 2|
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|
|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|
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.
- Compare serological status to predicate device [ Time Frame: End of study ]
Biospecimen Retention: Samples With DNA
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
|United States, California|
|Providence Clinical Research|
|Burbank, California, United States, 91505|