Limitations for Current Technologies Used in Blood Safety

Direct detection of viral antigens and virus-specific antibodies have been the common tools for diagnosis of virus infections in the past 10 years. There are some limitations. For direct detection of virus antigens, shortly after virus infection, only a few viruses release antigens in amounts sufficiently detectable in the body by antibody assay. For indirect virus detection by virus specific antibodies [e.g., an

Table 21.1. Licensed / Approved Clinical HIV, HTLV and Hepatitis Tests (Source: Center for Biologies Evaluation and Research, US Food and Drug Administration)

Tradename(s)

Format

Sample

Manufacturer

Approval Date

Auszyme Monoclonal

Genetic Systems HBsAg EIA 3.0 EIA

Antibody to Hepatitis B Surface Antigen (HBsAg Assay) Serum/Plasma Donor Screen & Conf Kit

Serum/Plasma/ Donor Screen & Conf Kit

Cadaveric Serum

ORTHO Antibody to HBsAg ELISA Test System 3

Coulter HIV-1 p24 Ag Assay; HIV-1 p24 Antigen ELISA Test System

Coulter HIV-1 p24 Ag Assay

Epitope OraSure HIV-1 Oral Specimen Collection Device

Home Access HIV-1 Test System

Serum/Plasma

Donor Screen / Diagnosis & Conf Kit

Abbott Laboratories Abbott Park, IL US License 0043 Bio-Rad Laboratories Redmond, WA 98052 US License 1109 Ortho-Clinical Diagnostics, Inc Raritan, NJ 08869 US License 1236

Antibody to Human Immunodeficiency Viras (HIV-1 Antigen Assay) EIA Serum/Plasma Donor Screen/Prognosis & Coulter Corporation

Neut Kit Miami, FL

US License 1185

Oral Specimen Collection Device

Prognosis (Quantitative) & Neut Kit

Dried Blood Spot Collection Device

Viral Culture Supernatant

Anti-HIV-1 Oral Specimen Collection Device

Oral Fluid For Use in Designated

Non-Donor Screen and Non-Donor Supplemental

Assays

Anti-HIV-1 Testing Service

Dried Blood Spot Non-Donor Screen

Coulter Corp

Home Access Health Corp Hoffman Estates, IL

4/1/1985

1/23/2003

4/23/2003

3/14/1996

3/14/1996

Epitope, Inc Beaverton, OR 12/23/1994

7/22/1996

Ausab

Ausab EIA Corzyme

Ortho HBc ELISA Test System

Abbott HCV EIA 2.0

Ortho HCV Version 3.0 ELISA Test System

Chiron RIBA HCV 3.0 Strip Immunoblot Assay

Roche Amplicor HIV-1 Monitor Test

NucliSens HIV-1 QT

COBAS Ampliscreen HIV-1 Test Procleix

EIA EIA

EIA EIA

NASBA

Hepatitis B Surface Antigen (Anti-HBs Assay) Serum/Plasma Anti-HBs

Serum/Plasma Anti-HBs

Hepatitis B Virus Core Antigen (Anti-HBc Assay) Serum/Plasma Donor Screen

Serum/Plasma

Donor Screen

Hepatitis C Virus Encoded Antigen (Anti-HCV Assay) Serum/Plasma Donor Screen

Serum/Plasma

Serum/Plasma

Donor Screen

Donor Supplemental

HIV-1/HCV Nucleic Acid Testing

Plasma

Plasma

Plasma

HIV-1/ HCV Nucleic Plasma Acid Test (TMA)

Prognosis / Patient

Management HIV-1 Viral Load Assay Prognosis / Patient

Management HIV-1 Viral Load Assay Donor Screen

Donor Screen

Abbott Laboratories 2/5/1975 Abbott Park, IL US License 0043

Abbott Laboratories 11/18/1982

Abbott Laboratories 3/19/1991 Abbott Park, IL US License 0043

Ortho-Clinical Diagnostics, 4/18/1991 Inc Raritan, NJ US License 1236

Abbott Laboratories Abbott 5/6/1992 Park, IL US License 0043

Ortho-Clinical Diagnostics, 5/20/1996 Inc Raritan, NJ US License 1236

Chiron Corp Emeryville, CA 2/11/1999 US License 1106

Roche Molecular Systems, 3/2/1999 Inc Branchburg Township, NJ

bioMerieux, Inc Durham, 11/19/2001 NC 27712

Roche Molecular Systems, 12/20/2002 Inc Pleasanton, CA 94566

Gen-Probe San Diego, 2/8/2002 CA 92121

(icontinued)

TABLE 21.1. (Continued)

Tradename(s)

Format

Sample

Manufacturer

Approval Date

Tragene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System

UltraQual HIV-1 RT-PCR Assay

UltraQual HCV RT-PCR Assay

ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer

Versant HIV-1 RNA 3.0 (bDNA) COBAS AmpliScreen HCV Test

HIVAB HIV-1 EIA

Genetic Systems rLAV EIA

Murex SUDS HIV-1 Test

HIV-1 Genotyping Plasma

PCR PCR

Plasma Plasma

HIV-1 Genotyping Plasma

Signal amplification Plasma nucleic acid probe PCR Plasma

Patient Monitoring

Donor Screen

Donor Screen

Detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drags, such as an aid in monitoring and treating HIV infection

Patient Monitoring

Donor Screen

Visible Genetics, Inc Toronto, CA

4/24/2002

Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay) EIA Serum/Plasma Donor Screen

Rapid EIA

Serum/Plasma

Serum/Plasma

Donor Screen

Donor Screen

National Genetics Institute Los 9/18/2001

Angeles, CA 92121

National Genetics Institute Los 9/18/2001

Angeles, CA 92121

Celera Diagnostics Alameda, 6/11/2003 CA 94502

Bayer Corp Berkeley, CA 9/11/2002 94702

Roche Molecular Systems, Inc 12/3/2002 Pleasanton, CA 94566

Abbott Laboratories 3/1/1985

Abbott Park, IL US License 0043 Bio-Rad Laboratories Blood 6/29/1998 Virus Division Redmond, WA US License 1109 Murex Diagnostics, Inc 5/22/1992

Norcross, GA US License 1152

Vironostika HIV-1 Microelisa EIA

System

Serum/Plasma

Vironostika HIV-1 Plus O Microelisa EIA System

Cambridge Biotech HIV-1 Western WB Blot Kit

Genetic Systems HIV-1 Western Blot WB

Fluorognost HIV-1 IFA IFA

Plasma/Serum/Dried Blood Spots

Serum/Plasma

Serum/Plasma Serum/Plasma

HIVAB HIV-1 EIA HIV-1 Urine EIA Genetic Systems rLAV EIA

EIA EIA EIA

Dried Blood Spot Urine Screen Dried Blood Spot

Vironostika HIV-1 Microelisa System

Oral Fluid Vironostika HIV-1

Microelisa System Cambridge Biotech HIV-1 Western Blot Kit

Genetic Systems HIV-1 Western Blot

OraSure HIV-1 Western Blot Kit Fluorognost HIV-1 IFA

OraQuick Rapid HIV-1 Antibody Test

EIA Dried Blood Spot

EIA Oral Fluid

WB Urine

WB Dried Blood Spot

WB Oral Fluid

IFA Dried Blood Spot

Rapid EIA Fingerstick

Donor Screen

Diagnostic Non-Donor Screen Donor Supplemental

Donor Supplemental Donor Supplemental

Non-Donor Screen Non-Donor Screen Non-Donor Screen

Non-Donor Screen

Non-Donor Screen

Non-Donor Supplemental bioMerieux, Inc Durham, NC 27712 US License 1624 bioMerieux, Inc Durham, NC 27712 US License 1624 Calypte Biomedical Corp Berkeley, CA US License 1207 Bio-Rad Laboratories Blood

Virus Division Waldheim Pharmazeutika GmbH Vienna, Austria US License 1150 Abbott Laboratories Calypte Biomedical Corp Bio-Rad Laboratories Blood

Virus Division bioMerieux, Inc

Durham, NC 27712 bioMerieux, Inc

Durham, NC 27712 Calypte Biomedical Corp

Non-Donor Supplemental

Non-Donor Supplemental Non-Donor Supplemental

Non-Donor Screen

Bio-Rad Laboratories Blood

Virus Division Epitope, Inc

Waldheim Pharmazeutika

GmbH OraSure Technologies, Inc Bethlehem, PA 18015

12/18/1987

6/6/2003

1/3/1991

11/13/1998 2/5/1992

4/22/1992

8/6/1996

6/29/1998

4/11/1990

12/23/1994

5/28/1998

11/13/1998

6/3/1996 5/14/1996

11/7/2002

(continued)

TABLE 21.1. (Continued)

Tradename(s)

Format

Sample

Manufacturer

Approval Date

Reveal Rapid HIV-1 Antibody Test Rapid Immunoassay Serum/Plasma

Non-Donor Screen

Uni-Gold Recombigen HIV

Abbott HIVAB HIV-l/HIV-2 (rDNA) EIA

Genetic Systems HIV-l/HIV-2 Peptide EIA

Genetic Systems HIV-l/HIV-2 Plus O EIA

Genetic Systems HIV-2 EIA

Abbott HTLV-I/HTLV-II EIA

Vironostika HTLV-I/II Microelisa System

Rapid Immunoassay Serum/Plasma/Whole Non-Donor Screen Blood

Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay) EIA Serum/Plasma Donor Screen

Serum/Plasma/ Donor Screen

Cadaveric Serum

Serum/Plasma

Donor Screen

Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay) Serum/Plasma Donor Screen

MedMira Laboratories, Inc Halifax, Nova Scotia Canada B3S 1B3 Trinity Biotech, pic

Bray Co., Wicklow Ireland

Abbott Laboratories Abbott Park, IL US License 0043 Bio-Rad Laboratories Blood Virus Division Redmond, WA US License 1109 Bio-Rad Laboratories Inc Hercules, CA US License 1109

Bio-Rad Laboratories Blood Virus Division Redmond, WA US License 1109

Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay) EIA Serum/Plasma Donor Screen

Serum/Plasma

Donor Screen

Abbott Laboratories Abbott Park, IL US License 0043 bioMerieux, Inc Durham, NC 27712 US License 1624

4/16/2003

12/23/2003

2/14/1992

12/9/2000

8/5/2003

4/25/1990

8/15/1997

1/17/1998

immunofluorescence assay or enzyme immunoassay (EIA), etc.], there is aproblem in that shortly after infection by a pathogenic virus, there is a window period in which antibody generation is insufficient for detection (Chamberland, 2001). To reduce this window period, direct nucleic acid tests are needed.

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