Clinical trial NCT00655434: HerpeSelect® Express Rapid Test Study Protocol: Sexually Active Adult Population
Official title: HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Simplex Virus 2
Keywords: Herpes simplex virus 2
HSV 2
Antibody status to Herpesvirus 2, Human
Lead sponsor: Focus Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community based research clinic

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).

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 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

Primary outcomes:
measure: Compare serological status to predicate device
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
Study officials:
References: