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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2012

Interventions

  • Device: In Vitro Diagnostic Device
    • For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Arms, Groups and Cohorts

  • Known HIV positive
    • Patients from HIV clinics with documented infections
  • 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.
  • 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…

Clinical Trial Outcome Measures

Primary Measures

  • 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).
    • Time Frame: 20 minutes

Secondary Measures

  • 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.
    • Time Frame: 20 minutes

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chembio Diagnostic Systems, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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