HIV Test Kit
There are many HIV test kits available. Some are approved for home use while others are for use in Hospitals or by Doctors only.
At our Clinics, we use the Determine HIV 1/2 Rapid Test, the OraQuick Advance HIV 1/2 Rapid Test and the SD Bioline HIV Ag/Ab Combo Test.
The other HIV test kits approved for use by the US FDA are:
| Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits | |||||||
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
| Home Access HIV-1 Test System | HIV-1 | Dried Blood Spot Collection Device | Dried Blood Spot | In Vitro Diagnostic: Self-use by people who wish to obtain anonymous HIV testing | Home Access Health Corp., Hoffman Estates, IL |
7/22/1996 | BP950002 |
| OraSure HIV-1 Oral Specimen Collection Device | HIV-1 | Oral Specimen Collection Device | Oral Fluid | For Use with HIV diagnostic assays that have been approved for use with this device. | OraSure Technologies Bethlehem, PA |
12/23/1994 | BP910001 |
| OraQuick In-Home HIV Test | HIV-1, HIV-2 | Immunoassay | Oral fluid | Over-the-counter (OTC) diagnostic home-use test. A positive result is preliminary and follow-up confirmatory testing is needed. | OraSure Technologies Bethlehem, PA |
07/03/2012 | BP120001 |
| Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2) | |||||||
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
| Genetic Systems HIV-2 EIA | HIV-2 | EIA | Serum / Plasma | In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-2. |
Bio-Rad Laboratories Redmond, WA US License 1109 |
4/25/1990 | BL103227 |
| Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2) | |||||||
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
| ABBOTT PRISM HIV O Plus assay | HIV-1, HIV-2 | ChLIA | Plasma / Serum/ Cadaveric Serum | In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-1 groups M and O and/or antibodies to HIV-2. |
Abbott Laboratories Abbott Park, IL US License 0043 |
9/18/2009 | BL125318 |
| Genetic Systems HIV-1/HIV-2 Plus O EIA | HIV-1, HIV-2 | EIA | Serum / Plasma / Cadaveric Serum | In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2. |
Bio-Rad Laboratories Redmond, WA US License 1109 |
8/5/2003 | BL125030 |
| ADVIA Centaur HIV 1/O/2 RapidTest | HIV-1, HIV-2 | Microparticle Chemi-luminometric Immunoassay | Plasma/Serum | In Vitro Diagnostic: Qualitative determination of antibodies to HIV-1, including Group O, and/or HIV-2. | Siemens Healthcare Diagnostics, Inc. | 5/18/2006 | BP050030 |
| VITROS HIV-1/HIV-2 Reagent Pack and Calibrator | HIV-1, HIV-2 | Immunometric | Plasma/Serum | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2. | Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 |
3/27/2008 | BP050051 |
| Multispot HIV-1/HIV-2 Rapid Test | HIV-1, HIV-2 | Rapid Immunoassay | Plasma / Serum | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2. | Bio-Rad Laboratories Redmond, WA US License 1109 |
11/12/2004 | BP040046 |
| SURE CHECK HIV 1/2 ASSAY | HIV-1, HIV-2 | Rapid Immunoassay | Fingerstick & venous whole blood, serum, plasma | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Chembio Diagnostic Systems, Inc. Medford, NY |
5/25/2006 | BP050009 |
| HIV 1/2 STAT-PAK ASSAY | HIV-1, HIV-2 | Rapid Immunoassay | Fingerstick & venous whole blood, serum, plasma | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Chembio Diagnostic Systems, Inc. Medford, NY |
5/25/2006 | BP050010 |
| OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | HIV-1, HIV-2 | Rapid Immunoassay | Oral Fluid, Plasma, Whole Blood (venipuncture and fingerstick) | In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | OraSure Technologies Bethlehem, PA |
11/7/2002 6/22/2004 |
BP010047 |
| Chembio DPP® HIV 1/2 Assay | HIV-1, HIV-2 | Rapid Immuno-chromatographic Assay | Oral Fluid, Serum, Plasma, Whole Blood (Venipuncture, Fingerstick) |
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Chembio Diagnostic Systems, Inc. Medford, NY |
12/19/2012 | BP120032 |
| Uni-Gold™ Recombigen® HIV-1/2 | HIV-1, HIV-2 | Rapid EIA | Serum, Plasma, Whole Blood (Venipuncture, Fingerstick) |
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test. | Trinity Biotech Jamestown, NY |
12/23/2003 02/04/2013 |
BP030025 |
| Anti-HIV-1/2 and HIV-1 Antigen Combo Assays (detect HIV-1 antigen and antibodies to HIV Types 1 and 2) | |||||||
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
| ARCHITECT HIV Ag/Ab Combo | HIV-1, HIV-2 | CMIA | Plasma / Serum | In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2. | Abbott Laboratories Abbott Park, IL US License 0043 |
6/18/2010 | BP090080 |
| GS HIV Ag/Ab Combo EIA | HIV-1, HIV-2 | EIA | Plasma / Serum | In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2. | Bio-Rad Laboratories Redmond, WA US License 1109 |
7/22/2011 | BP100064 |
| Alere DetermineTM HIV-1/2 Ag/Ab Combo |
HIV-1, HIV-2 | Immunoassay | Serum, Plasma, Whole Blood (Venipuncture, Fingerstick) |
In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 and/or HIV-2; point-of-care test. | Alere Scarborough, Inc. Scarborough, ME |
8/8/2013 | BP120037 |
Information Courtesy of US FDA Website
Home HIV tests are never 100% accurate. If you choose to do use a Home HIV Test Kit, you should still verify the result with a Doctor.
This is especially so if the result is positive.