Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen & Conf Kit |
Abbott Laboratories |
4/1/1985 |
|
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen & Conf Kit |
Bio-Rad Laboratories |
1/23/2003 |
|
ORTHO Antibody to HBsAg ELISA Test System 3 |
EIA |
Serum / Plasma |
Donor Screen / Diagnosis & Conf Kit |
Ortho-Clinical Diagnostics, Inc |
4/23/2003 |
Chemiluminescent Immunoassay (ChLIA) |
Serum/Plasma |
Donor screening test to detect HBsAg. Also for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and intesting blood specimens to screen cadaveric (non-heart-beating) donors. |
Abbott Laboratories |
7/18/2006 |
Anti-HIV-1 Oral Specimen Collection Device
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
OraSure HIV-1 Oral Specimen Collection Device |
Oral Specimen Collection Device |
Oral Fluid |
For Use with HIV diagnostic assays that have been approved for use with this device. |
OraSure Technologies |
12/23/1994 |
Anti-HIV-1 Testing Service
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
Dried Blood Spot Collection Device |
Dried Blood Spot |
Diagnostic |
Home Access Health Corp |
7/22/1996 |
Hepatitis B Surface Antigen (Anti-HBs Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
Ausab EIA |
EIA |
Serum / Plasma |
Anti-HBs |
Abbott Laboratories |
11/18/1982 |
Hepatitis B Virus Core Antigen (Anti-HBc Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
CORZYME |
EIA |
Serum / Plasma |
Donor Screen |
Abbott Laboratories |
3/19/1991 |
Ortho HBc ELISA Test System |
EIA |
Serum / Plasma |
Donor Screen |
Ortho-Clinical Diagnostics, Inc |
4/18/1991 |
Chemiluminescent Immunoassay (ChLIA) |
Serum / Plasma |
Donor Screen |
Abbott Laboratories |
10/13/2005 |
Hepatitis C Virus Encoded Antigen (Anti-HCV Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen |
Abbott Laboratories |
5/6/1992 |
|
Ortho HCV Version 3.0 ELISA Test System | EIA |
Serum / Plasma |
Donor Screen |
Ortho-Clinical Diagnostics, Inc |
5/20/1996 |
SIA |
Serum / Plasma |
Donor Supplemental |
Chiron Corp |
2/11/1999 |
|
Chemiluminescent Immunoassay (ChLIA) |
Serum / Plasma |
Donor screening test for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens. Also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. |
Abbott Laboratories |
7/11/2007 |
Nucleic Acid Testing
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
PCR |
Plasma |
Prognosis / Patient Management |
Roche Molecular Systems, Inc |
3/2/1999 |
|
NASBA |
Plasma |
Prognosis / Patient Management |
bioMerieux, Inc |
11/19/2001 |
|
PCR |
Plasma |
Donor Screen |
Roche Molecular Systems, Inc |
12/20/2002 |
|
HIV-1/HCV Nucleic Acid Test (TMA) |
Plasma |
Donor Screen |
Gen-Probe |
6/4/2004 |
|
Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System |
HIV-1 Genotyping |
Plasma |
Patient Monitoring |
Siemens Medical Solutions Diagnostics |
4/24/2002 |
PCR |
Plasma |
Donor Screen |
National Genetics Institute |
9/18/2001 |
|
PCR |
Plasma |
Donor Screen |
National Genetics Institute |
9/18/2001 |
|
ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer |
HIV-1 Genotyping |
Plasma |
Patient Monitoring |
Celera Diagnostics |
6/11/2003 |
Signal amplification nucleic acid probe |
Plasma |
Patient Monitoring |
Siemens Medical Solutions Diagnostics Berkeley, CA |
9/11/2002 |
|
PCR |
Plasma |
Donor Screen |
Roche Molecular Systems, Inc |
12/3/2002 |
|
PCR |
Plasma |
Donor Screen |
Roche Molecular Systems, Inc |
4/21/2005 |
|
Nucleic Acid Test (TMA) |
Plasma |
Qualitative detection of West Nile Virus (WNV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor's heart is still beating, and test blood specimens to screen cadaveric donors |
Gen-Probe |
12/1/2005 |
|
Nucleic Acid Test (TMA) |
Plasma and Serum |
Qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor's heart is still beating, and test blood specimens to screen cadaveric donors. |
Gen-Probe |
10/3/2006 |
|
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay |
PCR |
Plasma |
Qualitative detection of HCV ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. |
BioLife Plasma Services, L.P. |
2/9/2007 |
PCR |
Plasma |
Qualitative detection of HIV-1 ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. |
BioLife Plasma Services, L.P. |
1/31/2007 |
|
PCR |
Plasma |
Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System. Not intended to be used as a donor screening test. | ABBOTT Molecular, Inc |
5/11/2007 |
|
PCR |
Plasma |
Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid. Not intended to be used as a donor screening test. |
Roche Molecular Systems, Inc |
5/11/2007 |
|
PCR |
Plasma |
For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. Also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating. |
Roche Molecular Systems, Inc |
8/28/2007 |
Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
EIA |
Serum / Plasma |
Donor Screen |
Bio-Rad Laboratories Redmond, WA |
6/29/1998 |
|
Cambridge Biotech HIV-1 Western Blot Kit |
WB |
Serum / Plasma |
Donor Supplemental |
Calypte Biomedical Corp |
1/3/1991 |
GS HIV-1 Western Blot |
WB |
Serum / Plasma |
Donor Supplemental |
Bio-Rad Laboratories |
11/13/1998 |
Fluorognost HIV-1 IFA |
IFA |
Serum / Plasma |
Donor Supplemental |
Waldheim Pharmazeutika GmbH |
2/5/1992 |
HIVAB HIV-1 EIA |
EIA |
Dried Blood Spot |
Diagnostic |
Abbott Laboratories |
4/22/1992 |
HIV-1 Urine EIA |
EIA |
Urine Screen |
Diagnostic |
Calypte Biomedical Corp |
8/6/1996 |
EIA |
Dried Blood Spot |
Diagnostic |
Bio-Rad Laboratories |
6/29/1998 |
|
WB |
Urine |
Diagnostic Supplemental |
Maxim Biomedical, Inc |
5/28/1998 |
|
GS HIV-1 Western Blot |
WB |
Dried Blood Spot |
Diagnostic Supplemental |
Bio-Rad Laboratories |
11/13/1998 |
WB |
Oral Fluid |
Diagnostic Supplemental |
OraSure Technologies |
6/3/1996 |
|
Fluorognost HIV-1 IFA |
IFA |
Dried Blood Spot |
Diagnostic Supplemental |
Waldheim Pharmazeutika GmbH |
5/14/1996 |
Rapid Immunoassay |
Serum / Plasma |
Diagnostic |
MedMira Laboratories, Inc |
4/16/2003 |
|
Rapid Immunoassay |
Serum / Plasma / Whole Blood |
Diagnostic |
Trinity Biotech, plc |
12/23/2003 |
Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen |
Abbott Laboratories |
2/14/1992 |
|
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen |
Bio-Rad Laboratories |
8/5/2003 |
|
Rapid Immunoassay |
Plasma / Serum |
Diagnostic |
Bio-Rad Laboratories |
11/12/2004 |
|
Rapid Immunoassay |
Whole Blood, Plasma, Oral Fluid |
Diagnostic |
OraSure Technologies |
6/22/2004 |
|
Microparticle Chemiluminometric Immunoassay |
Plasma/Serum |
Diagnostic for qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma |
Siemens Medical Solutions Diagnostics |
5/18/2006 |
|
Rapid Immunoassay |
Fingerstick & venous whole blood, serum, plasma |
Diagnostic |
Chembio Diagnostic Systems, Inc |
5/25/2006 |
Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
GS HIV-2 EIA |
EIA |
Serum / Plasma |
Donor Screen |
Bio-Rad Laboratories |
4/25/1990 |
Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
EIA |
Serum / Plasma |
Donor Screen |
Abbott Laboratories |
8/15/1997 |
|
Chemiluminescent Immunoassay (ChLIA) | Serum / Plasma | To be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor’s heart is still beating. | Abbott Laboratories Abbott Park, IL US License 0043 |
1/16/2008 |
Trypanosoma cruzi (T. cruzi) (Anti- T. cruzi Assay)
Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
---|---|---|---|---|---|
EIA |
Serum / Plasma |
Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors. Also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating |
Ortho-Clinical Diagnostics, Inc |
12/13/2006 |