Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population

Chembio Diagnostic Systems

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00567749

02-HIV02.01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 Form.
• Must have a parent or guardian present to sign and receive a copy of the Informed Consent Form.
• 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 only.

Exclusion criteria

• 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.

Trial design

10 participants in 1 patient group

A, Observational