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

Study Overview
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Brief Summary
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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.

Official Title
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Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma

Conditions
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HIV Infections

Intervention / Treatment
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* Device: In Vitro Diagnostic Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Known HIV positive<br>Patients from HIV clinics with documented infections | Device: In Vitro Diagnostic Device<br>* For the detection of antibodies to HIV in serum, plasma, blood and oral fluid<br>|
| High Risk for Infection with HIV<br>Patients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease. | Device: In Vitro Diagnostic Device<br>* For the detection of antibodies to HIV in serum, plasma, blood and oral fluid<br>|
| Low-Risk for Infection with HIV<br>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… | Device: In Vitro Diagnostic Device<br>* For the detection of antibodies to HIV in serum, plasma, blood and oral fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant). |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary. |  | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human immunodeficiency virus, Rapid Test, HIV, HIV Seronegativity