Herpes Simplex Virus 2NCT00655434
HerpeSelect® Express Rapid Test Study Protocol: Sexually Active Adult Population
An observational study of Herpes Simplex Virus 2, run by Focus Diagnostics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex Virus 2
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community based research clinic
Who may be able to join
- 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.
Who cannot join
- <18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Clinical Research
Burbank, California, 91505
About this study
Official title: HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population
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).
Read the 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.
- Conditions
- Herpes Simplex Virus 2
- Keywords
- Herpes simplex virus 2, HSV 2, Antibody status to Herpesvirus 2, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare serological status to predicate device
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex Virus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Focus Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655434
- Sponsor's protocol ID
- 06-001-RT0920G Rev:03/07/08
- Status last verified
- Jan 2009
- First submitted
- 2 Apr 2008
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population
- ClinicalTrials.gov ID
- NCT00655434
- Acronym / sponsor ID
- 06-001-RT0920G Rev:03/07/08
- Conditions
- Herpes Simplex Virus 2
- Keywords
- Herpes simplex virus 2, HSV 2, Antibody status to Herpesvirus 2, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Focus Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community based research clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare serological status to predicate device
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex Virus 2, run by Focus Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare serological status to predicate device (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2009.