Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test

Chembio Diagnostic Systems

Status: Completed

Conditions: HIV Infections

Treatments: Device: In Vitro Diagnostic Device

Study type: Observational

Funder types: Industry

Identifiers

NCT01032902

CP-HIV01

IDE 14208

Details and patient eligibility

About

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.

Enrollment: 2,808 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be at least 2 years of age (no upper age limit).
• Must be willing and able to receive post-test counseling, if applicable.
• Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
• Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion criteria

• Am in a life threatening condition at the time of enrollment
• Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
• Have participated or are participating in a clinical trial for an HIV vaccine.
• Have previously participated in this clinical trial.

Trial design

2,808 participants in 3 patient groups

Known HIV positive

Description:

Patients from HIV clinics with documented infections

Treatment:

Device: In Vitro Diagnostic Device

High Risk for Infection with HIV

Description:

Patients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease.

Treatment:

Device: In Vitro Diagnostic Device

Low-Risk for Infection with HIV

Description:

Individuals not known to belong to any of the defined high-risk groups - i.e. "healthy patients" presenting for routine physicals or other unrelated non-life threatening illnesses, or individuals from a general low risk population such as students, employees of academic or other institutions, etc…

Treatment:

Device: In Vitro Diagnostic Device