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
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.
- Must be at least 12 years of age and no older than 17 years of age.
- Must be willing to sign (and be given) a copy of the written Information and Assent
- Must have a parent or guardian present to sign and receive a copy of the Informed
- Must be able to provide one or two fingerstick blood samples.
- Must be able to provide three tubes of blood by venipuncture from the arm or hand
- Have a life threatening illness (with the exception of HIV or AIDS).
- Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed
with non-HIV immunosuppressive illness, etc.), as determined by interviewing the
study participant or parent/legal guardian.
- Have participated or are participating in a clinical trial for an HIV vaccine (as
determined by interviewing the study participant or parent/legal guardian).
- Have previously participated in this clinical trial (no duplicate enrollments).
- Are currently on HAART, except as agreed on a case-by-case basis.