Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
This study has been completed.
Sponsor:
Chembio Diagnostic Systems, Inc.
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01032902
First received: December 15, 2009
Last updated: April 27, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Device: In Vitro Diagnostic Device |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Chembio Diagnostic Systems, Inc.:
Primary Outcome 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 ] [ Designated as safety issue: No ]
Secondary Outcome 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum and plasma
| Enrollment: | 2808 |
| Study Start Date: | January 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Point-of-care test sites including clinics and physician office settings
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032902
Locations
| United States, California | |
| Univeristy of California, San Diego | |
| La Jolla, California, United States, 92093 | |
| United States, Florida | |
| Therafirst | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201-1559 | |
| United States, Pennsylvania | |
| St. Christopher's Hospital for Children/ Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| United States, Texas | |
| University of Texas HSC | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Chembio Diagnostic Systems, Inc.
More Information
No publications provided
| Responsible Party: | Chembio Diagnostic Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT01032902 History of Changes |
| Other Study ID Numbers: | CP-HIV01, IDE 14208 |
| Study First Received: | December 15, 2009 |
| Last Updated: | April 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Chembio Diagnostic Systems, Inc.:
|
Human immunodeficiency virus Rapid Test HIV HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013