Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
Completed
- Conditions
- HIV Infections
- Interventions
- Device: In Vitro Diagnostic Device
- Registration Number
- NCT01032902
- Lead Sponsor
- Chembio Diagnostic Systems, Inc.
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2808
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Known HIV positive In Vitro Diagnostic Device Patients from HIV clinics with documented infections High Risk for Infection with HIV In Vitro Diagnostic Device 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 In Vitro Diagnostic Device 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...
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (5)
University of Texas HSC
🇺🇸Houston, Texas, United States
Univeristy of California, San Diego
🇺🇸La Jolla, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Therafirst
🇺🇸Fort Lauderdale, Florida, United States
St. Christopher's Hospital for Children/ Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States