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

NCT ID: NCT01032902

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2808 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-04-30

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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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Human immunodeficiency virus Rapid Test HIV HIV Seronegativity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Known HIV positive

Patients from HIV clinics with documented infections

In Vitro Diagnostic Device

Intervention Type DEVICE

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

High Risk for Infection with HIV

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

In Vitro Diagnostic Device

Intervention Type DEVICE

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Low-Risk for Infection with HIV

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…

In Vitro Diagnostic Device

Intervention Type DEVICE

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Interventions

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In Vitro Diagnostic Device

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Intervention Type DEVICE

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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chembio Diagnostic Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Univeristy of California, San Diego

La Jolla, California, United States

Site Status

Therafirst

Fort Lauderdale, Florida, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

St. Christopher's Hospital for Children/ Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

University of Texas HSC

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IDE 14208

Identifier Type: -

Identifier Source: secondary_id

CP-HIV01

Identifier Type: -

Identifier Source: org_study_id