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

Chembio Diagnostic Systems, Inc.10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infections

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Laboratory of Viral Diagnostics, University of Maryland School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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