Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-06 @ 12:10 PM
Study NCT ID:
NCT00655434
Status:
COMPLETED
Last Update Posted:
2009-01-09
First Post:
2008-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HerpeSelect® Express Rapid Test Study Protocol: Sexually Active Adult Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-08', 'studyFirstSubmitDate': '2008-04-02', 'studyFirstSubmitQcDate': '2008-04-08', 'lastUpdatePostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare serological status to predicate device', 'timeFrame': 'End of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Herpes simplex virus 2', 'HSV 2', 'Antibody status to Herpesvirus 2, Human'], 'conditions': ['Herpes Simplex Virus 2']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': "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).\n\nThis 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.\n\nTest 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community based research clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sexually Active Adults - Intercourse in the last twelve months with at least one sexual partner.\n* Subjects must be ≥ 18 years old.\n* No more than 60% of one gender.\n\nExclusion Criteria:\n\n* \\<18 years old'}, 'identificationModule': {'nctId': 'NCT00655434', 'briefTitle': 'HerpeSelect® Express Rapid Test Study Protocol: Sexually Active Adult Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Focus Diagnostics, Inc.'}, 'officialTitle': 'HerpeSelect® Express Rapid Test Study Protocol Sexually Active Adult Population', 'orgStudyIdInfo': {'id': '06-001-RT0920G Rev:03/07/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SAA', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Focus Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John Hurrell/Vice President General Manager', 'oldOrganization': 'Focus Diagnostics, Inc.'}}}}