Procleix UltrioPlex E Assay (CE Marked)
Single-tube, highly sensitive detection of HEV RNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
Assay Characteristics
Assay chemistry
- Procleix Panther system
-
Qualitative, transcription-mediation 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, or in a gel separation tube
Pool sizes
- Procleix Panther system
-
IDT-NAT, Pools of 4, 8, 16, or 96
Assay kit size
- Procleix Panther system
-
1000 or 5000 tests
Detected virus
- Procleix Panther system
-
HIV-1 group M subtypes A, B, C, D, E, F, G, H, J, K and L, recombinant forms BF, BG, CRF01_AE, CRF02_AG, and CRF37_cpx, group N, group O and group P; HIV-2 subptypes A and B; HCV genotypes 1-8, and subtypes 1a, 1b, 2a/2c, 2b, 3a, 3b, 3e, 4a, 4b/4c, 5a, 6a, 6c, 7a, 7b, and 8a; HBV genotypes A-J and pre-core mutants with G1896A and/or C1858T mutations; HEV genotypes 1-8, and subtypes 1a, 1e, 2a, 3a, 3b, 3c, 3e, 3f, 3h, 3i, 4b, 4c, 5a, 6, 7, and 8
| Platform | Procleix Panther system |
|---|---|
|
Assay chemistry |
Qualitative, transcription-mediation amplification (TMA) |
|
Indication |
Blood screening, source plasma, cadaveric (non-heart-beating) donors |
|
Collection tube |
Serum or plasma collected in K2EDTA, K3EDTA, or in a gel separation tube |
|
Pool sizes |
IDT-NAT, Pools of 4, 8, 16, or 96 |
|
Assay kit size |
1000 or 5000 tests |
|
Detected virus |
HIV-1 group M subtypes A, B, C, D, E, F, G, H, J, K and L, recombinant forms BF, BG, CRF01_AE, CRF02_AG, and CRF37_cpx, group N, group O and group P; HIV-2 subptypes A and B; HCV genotypes 1-8, and subtypes 1a, 1b, 2a/2c, 2b, 3a, 3b, 3e, 4a, 4b/4c, 5a, 6a, 6c, 7a, 7b, and 8a; HBV genotypes A-J and pre-core mutants with G1896A and/or C1858T mutations; HEV genotypes 1-8, and subtypes 1a, 1e, 2a, 3a, 3b, 3c, 3e, 3f, 3h, 3i, 4b, 4c, 5a, 6, 7, and 8 |
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