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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.