|
Test
|
Name
|
Approved
For
Diagnostic
|
Approved
For Donor
Screening
|
Limitations
(Not All
Inclusive)
|
|
Antibody to Hepatitis B Surface Antigen (mouse monoclonal)
|
Genetic Systems™ HBsAg EIA 3.0
|
Yes
|
Yes
|
|
|
Abbott Prism® HBsAg
|
No
|
Yes
|
Not for cord blood specimens
|
|
Procleix® Ultrio® Assay
|
No
|
Yes
|
Approved as a detection test for donor specimens. Not for cord blood specimens
|
|
Hepatitis B Virus Core Antigen
|
Ortho HBc® Elisa Test System
|
Yes
|
Yes
|
|
|
Abbott Prism® Hbcore
|
No
|
Yes
|
|
|
Hepatitis C Virus Encoded Antigen
|
Ortho HCV Version 3.0 ELISA
|
Yes
|
Yes
|
|
|
Procleix® Ultrio® Assay
|
No
|
Yes
|
Not for cord blood
|
|
Human Immunodeficiency Virus Type 1 and 2
|
Genetic Systems™ HIV-1/HIV-2 PLUS O EIA
|
Yes
|
Yes
|
|
|
Human Immunodeficiency Virus Type 1
|
Procleix® Ultrio® Assay
|
No
|
Yes
|
Not for cord blood
|
|
Human T-Lymphotropic Viruses Type I and II
|
Abbott Prism® HTLV-I/HTLV-II Assay
|
No
|
Yes
|
|
|
Trypanosoma cruzi (T.cruzi) whole Cell Lysate Antigen
|
Ortho®T.cruzi ELISA Test System
|
No
|
Yes
|
Not for cord blood, not for non-heart beating donors
|
|
West Niles Virus (WNV)
|
Procleix® WNV ASSAY
|
No
|
Yes
|
Not for cord blood specimens
|
|
Antibody Detection
|
Capture-R *
|
No*
|
Yes
|
*manual method available
|
|
Antibody to Cytomegalovirus (CMV)
|
Capture-CMV
|
Yes
|
Yes
|
|
|
Antibody to Treponema Pallidum
|
TPHA TEST**
|
No*
|
Yes
|
**RPR available
|