Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
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|ClinicalTrials.gov Identifier: NCT00567749|
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : June 27, 2008
|Condition or disease|
In order to achieve the primary objective, clinical trials will be conducted to establish and confirm the sensitivity of the Clearview HIV 1/2 tests in the described pediatric population. Only HIV-1 will be included in the study.
The Clearview HIV tests can be used as a safe and effective screening method to aid in the diagnosis of infection with HIV 1/2 in the pediatric population aged between 12 and 17 years.
The secondary objectives of this study include demonstrating that:
- The Clearview HIV tests detect HIV-1 antibodies in a variety of sample matrices: capillary (fingertip) whole blood, venous whole blood, plasma and serum.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Clinical Sensitivity of the Clearview® COMPLETE HIV 1/2, PMA # BP050009 and the Clearview® HIV 1/2 STAT-PAK®, PMA #BP050010 in the 12 - 17 Year Old Pediatric Population|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- The Clearview HIV tests provide a 100% agreement with known HIV(+) status for all 10 eligible 12 to 17 year old individuals, at least one of whom will be age 12. [ Time Frame: 3-10 days ]
- The Clearview tests will be used in a representative clinical setting for the qualitative detection of antibodies to HIV-1 in fingerstick, venous whole blood, serum and plasma matrices. [ Time Frame: 3-10 days ]
Biospecimen Retention: Samples Without 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): NCT00567749
|United States, Maryland|
|Laboratory of Viral Diagnostics, University of Maryland School of Medicine|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Neil T. Constantine, Ph.D.||University of Maryland, Baltimore|