HIV Infections Clinical Trial
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
This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and 17 years of age. A minimum of ten (10) known HIV-positive participants will be tested.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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