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| ID | Type | Description | Link |
|---|---|---|---|
| IDE 14208 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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… |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In Vitro Diagnostic Device | Device | For the detection of antibodies to HIV in serum, plasma, blood and oral fluid |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Point-of-care test sites including clinics and physician office settings
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of California, San Diego | La Jolla | California | 92093 | United States | ||
| Therafirst |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D011933 | Reagent Kits, Diagnostic |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007202 | Indicators and Reagents |
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serum and plasma
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
| University of Maryland | Baltimore | Maryland | 21201-1559 | United States |
| St. Christopher's Hospital for Children/ Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| University of Texas HSC | Houston | Texas | 77030 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D004864 | Equipment and Supplies |