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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Device: In Vitro Diagnostic Device

• Study Type: Observational
• Enrollment (Actual): 2808

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Univeristy of California, San Diego
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Therafirst
  • Maryland
    • Baltimore, Maryland, United States, 21201-1559
      • University of Maryland
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • St. Christopher's Hospital for Children/ Drexel University College of Medicine
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas HSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Point-of-care test sites including clinics and physician office settings

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Known HIV positive; Patients from HIV clinics with documented infections	Device: In Vitro Diagnostic 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.	Device: In Vitro Diagnostic 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…	Device: In Vitro Diagnostic Device; For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chembio Diagnostic Systems, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): April 30, 2012
• Last Update Submitted That Met QC Criteria: April 27, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV; Human immunodeficiency virus; Rapid Test
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: CP-HIV01; IDE 14208