Procleix Ultrio Elite Assay (FDA Approved and CE Marked)
Single-tube, highly sensitive detection of HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
The Procleix Ultrio Elite assay is CE marked and FDA approved.
Assay Characteristics
Assay chemistry
- Procleix Panther system
-
Qualitative, transcription-mediated amplification (TMA)
Indication
- Procleix Panther system
-
Blood screening, source plasma, cadaveric (non-heart-beating) donors
Collection tube
- Procleix Panther system
-
Serum or plasma collected in K2EDTA, K3EDTA, Greiner K2EDTA sep collection tubes, or BD PPT tubes
Pool sizes
- Procleix Panther system
-
IDT-NAT, 4, 8, 16, 96
Assay kit size
- Procleix Panther system
-
1000 or 5000 tests
Detected virus
- Procleix Panther system
-
HIV-1 group M (subtypes A-H, K, CRF01_AE, CRF03_AB), N, O; HIV-2 subtypes A, B; HCV genotypes 1-6 (subtypes 1a, 1b, 2a/c, 2b, 3a, 3b, 3e, 4a, 4b/c, 5a, 6a); HBV genotypes A-H
| Platform | Procleix Panther system |
|---|---|
|
Assay chemistry |
Qualitative, transcription-mediated amplification (TMA) |
|
Indication |
Blood screening, source plasma, cadaveric (non-heart-beating) donors |
|
Collection tube |
Serum or plasma collected in K2EDTA, K3EDTA, Greiner K2EDTA sep collection tubes, or BD PPT tubes |
|
Pool sizes |
IDT-NAT, 4, 8, 16, 96 |
|
Assay kit size |
1000 or 5000 tests |
|
Detected virus |
HIV-1 group M (subtypes A-H, K, CRF01_AE, CRF03_AB), N, O; HIV-2 subtypes A, B; HCV genotypes 1-6 (subtypes 1a, 1b, 2a/c, 2b, 3a, 3b, 3e, 4a, 4b/c, 5a, 6a); HBV genotypes A-H |
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