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Back To Vidyya Licensed / Approved HIV, HTLV and Hepatitis Tests


Tests For Home And Office Use


A number of tests exist for HTLV, HIV and Hepatitis. Only those approved by the FDA are licensed for use in the United States. The following tables contain all US licensed tests for HTLV, HIV and Hepatitis. Where available, addresses of the companies responsible for the manufacture of the test kits are included. Some of the tests are for home use, most are for use in the hospital, office or laboratory.

Licensed Tests -
Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Ausria II RIA Serum / Plasma Donor Screen & Conf. Kit Abbott Laboratories
Abbott Park, IL
US License 0043
03/15/71
Auszyme Monoclonal EIA Serum / Plasma Donor Screen & Conf. Kit Abbott Laboratories 04/01/85
IMx HBsAg Micro- particle EIA Serum / Plasma Donor Screen & Conf. Kit Abbott Laboratories 12/01/95
Genetic Systems HBsAg EIA 2.0 EIA Serum / Plasma Donor Screen & Conf. Kit Genetic Systems Corp.
Redmond, WA
US License 0978
06/09/95
Hepanostika EIA Serum / Plasma Donor Screen & Conf.Kit Organon Teknika B.V.
Boxtel, The Netherlands
US License 1103
03/27/90
NML ELISA EIA Serum / Plasma Donor Screen & Conf. Kit Organon Teknika Corp.
Durham, NC
US License 0956
07/12/88
Ortho Antibody to HBsAg ELISA Test System 2 EIA Serum / Plasma Donor Screen & Conf. Kit Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
07/23/71
AUK-3 RIA Serum / Plasma Donor Screen & Conf. Kit DiaSorin s.r.l.
Saluggia, Italy
US License 1257
05/09/86
ETI-MAK-2;
Microtrak HBsAg EIA
EIA Serum / Plasma Donor Screen & Conf. Kit DiaSorin s.r.l. 04/18/95

Antibody to Human Immunodeficiency Virus (HIV-1 Antigen Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HIVAG-1 Monoclonal EIA Serum / Plasma Donor Screen / Prognosis & Neut. Kit Abbott Laboratories
Abbott Park, IL
US License 0043
04/23/96
Coulter HIV-1 p24 Ag Assay;
HIV-1 p24 Antigen ELISA Test System
EIA Serum / Plasma Donor Screen / Prognosis & Neut. Kit Coulter Corporation
Miami, FL
US License 1185
03/14/96
Abbott HIVAG-1 EIA Serum / Plasma Prognosis & Neut. Kit Abbott Laboratories 08/03/89
Coulter HIV-1 p24 Ag Assay EIA Viral Culture Supernatant Prognosis (Quantitative) & Neut. Kit Coulter Corporation 03/14/96

Hepatitis B Surface Antigen (Anti-HBs Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Ausab RIA Serum / Plasma Anti-HBs Abbott Laboratories
Abbott Park, IL
US License 0043
02/05/75
Ausab EIA EIA Serum / Plasma Anti-HBs Abbott Laboratories 11/18/82
AB-AUK-3 RIA Serum / Plasma Anti-HBs DiaSorin s.r.l.
Saluggia, Italy
US License 1257
06/27/89
ETI-AB-AUK;
Microtrak Anti-HBsurface EIA
EIA Serum / Plasma Anti-HBs DiaSorin s.r.l. 04/18/95

Hepatitis B Virus Core Antigen (Anti-HBc Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Corab RIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043
03/19/91
Corzyme EIA Serum / Plasma Donor Screen Abbott Laboratories 03/19/91
Hepanostika Anticore Microelisa System EIA Serum / Plasma Donor Screen Organon Teknika B.V.
Boxtel, The Netherlands
U.S. License 1103
03/29/91
Ortho HBc ELISA Test System EIA Serum / Plasma Donor Screen Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
04/18/91
AB-COREK RIA Serum / Plasma Donor Screen DiaSorin s.r.l.
Saluggia, Italy
US License 1257
03/19/91
ETI-AB-COREK EIA Serum / Plasma Donor Screen DiaSorin s.r.l. 03/19/91

Hepatitis C Virus Encoded Antigen (Anti-HCV Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HCV EIA 2.0 EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043
05/06/92
Ortho HCV Version 3.0 ELISA Test System EIA Serum / Plasma Donor Screen Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
05/20/96
Chiron RIBA HCV 3.0 Strip Immunoblot Assay SIA Serum / Plasma Donor Supplemental Chiron Corporation
Emeryville, CA
US License 1106
02/11/99

Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
HIVAB HIV-1 EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043
03/01/85
Recombigen (env & gag) HIV-1 EIA EIA Serum / Plasma Donor Screen Calypte Biomedical Corp.
Berkeley, CA
US License 1207
05/01/90
Microtrak HIV-1 EIA (env & gag) EIA Serum / Plasma Donor Screen Calypte Biomedical Corp. 05/30/90
rLAV EIA EIA Serum / Plasma Donor Screen Genetic Systems Corp.
Redmond, WA
US License 0978
06/29/98
Murex SUDS HIV-1 Test Rapid EIA Serum / Plasma Donor Screen Murex Diagnostics, Inc.
Norcross, GA
US License 1152
05/22/92
Vironostika HIV-1 Microelisa System EIA Serum / Plasma Donor Screen Organon Teknika Corp.
Durham, NC
US License 0956
12/18/87
UBI-OLYMPUS HIV-1 EIA EIA Serum / Plasma Donor Screen United Biomedical, Inc.
Hauppauge, NY
US License 1079
05/31/89
Novapath HIV-1 Immunoblot WB Serum / Plasma Donor Supplemental Bio-Rad Laboratories
Hercules, CA
US License 1109
06/15/90
Cambridge Biotech HIV-1 Western Blot Kit WB Serum / Plasma Donor Supplemental Calypte Biomedical Corp. 01/03/91
Genetic Systems HIV-1 Western Blot WB Serum / Plasma Donor Supplemental Genetic Systems Corp. 11/13/98
EPIblot HIV-1 WB Serum / Plasma Donor Supplemental Epitope, Inc.
Beaverton, OR
US License 1133
03/20/91
Fluorognost HIV-1 IFA IFA Serum / Plasma Donor Supplemental Waldheim Pharmazeutika G.m.b.H.
Vienna, Austria
US License 1150
02/05/92
HIVAB HIV-1 EIA EIA Dried Blood Spot Non-Donor Screen Abbott Laboratories 04/22/92
HIV-1 Urine EIA;
Seradyn Sentinel HIV-1 Urine EIA
EIA Urine Screen Non-Donor Screen Calypte Biomedical Corp. 08/06/96
rLAV EIA EIA Dried Blood Spot Non-Donor Screen Genetic Systems Corp. 06/29/98
Vironostika HIV-1 Microelisa System EIA Dried Blood Spot Non-Donor Screen Organon Teknika Corp. 04/11/90
Oral Fluid Vironostika HIV-1 Microelisa System EIA Oral Fluid Non-Donor Screen Organon Teknika Corp. 12/23/94
Cambridge Biotech HIV-1 Western Blot Kit WB Urine Non-Donor Supplemental Calypte Biomedical Corp. 5/28/98
Genetic Systems HIV-1 Western Blot WB Dried Blood Spot Non-Donor Supplemental Genetic Systems Corp. 11/13/98
OraSure HIV-1 Western Blot Kit WB Oral Fluid Non-Donor Supplemental Epitope, Inc. 06/03/96
Fluorognost HIV-1 IFA IFA Dried Blood Spot Non-Donor Supplemental Waldheim Pharmazeutika G.m.b.H. 05/14/96

Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043
02/14/92
Genetic Systems HIV-1/HIV-2 Peptide EIA EIA Serum / Plasma Donor Screen Genetic Systems Corp.
Redmond, WA
US License 0978
08/22/97
UBI HIV-1/2 EIA EIA Serum / Plasma Donor Screen United Biomedical, Inc.
Hauppauge, NY
U.S. License 1079
12/20/96

Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Genetic Systems HIV-2 EIA EIA Serum / Plasma Donor Screen Genetic Systems Corp.
Redmond, WA
US License 0978
04/25/90

Human T-Lymphotropic Virus Type I (Anti-HTLV-I Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Cambridge Biotech HTLV-I (rp21e enhanced) EIA EIA Serum / Plasma Donor Screen Calypte Biomedical Corp.
Berkeley, CA
US License 1207
09/08/95

Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay)
Tradename(s) Format Sample Use Manufacturer Approval Date
Abbott HTLV-I/HTLV-II EIA EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043
08/15/97
Vironostika HTLV-I/II Microelisa System EIA Serum / Plasma Donor Screen Organon Teknika Corp.
Durham, NC
US License 0956
01/17/98


Premarket Approvals -

Anti-HIV-1 Testing Service
Tradename(s) Format Sample Use Manufacturer Approval Date
Home Access HIV-1 Test System Dried Blood Spot Collection Device Dried Blood Spot Non-Donor Screen Home Access Health Corp.
Hoffman Estates, IL
07/22/96

Anti-HIV-1 Oral Specimen Collection Device
Tradename(s) Format Sample Use Manufacturer Approval Date
Epitope OraSure HIV-1 Oral Specimen Collection Device Oral Specimen Collection Device Oral Fluid For Use in Designated Non-Donor Screen and Non-Donor Supplemental Assays Epitope, Inc.
Beaverton, OR
05/09/91

HIV-1 Viral Load Assay
Tradename(s) Format Sample Use Manufacturer Approval Date
Roche Amplicor HIV-1 Monitor Test PCR Plasma Prognosis / Patient Management Roche Molecular Systems, Inc.
Branchburg Township, NJ
03/02/99

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Editor: Susan K. Boyer, RN
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