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 Performance 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 |
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
HIV/HCV/HBV
- # of samples
-
7948
- Specificity (%)
-
100
- 95% confidence interval
-
99.95 - 100
HEV
- # of samples
-
7948
- Specificity (%)
-
100
- 95% confidence interval
-
99.95 - 100
| Target region | # of samples | Specificity (%) | 95% confidence interval |
|---|---|---|---|
|
HIV/HCV/HBV |
7948 |
100 |
99.95 - 100 |
|
HEV |
7948 |
100 |
99.95 - 100 |
Analytical Sensitivity
HIV-1 WHO (16/194)
- 50% Detection Probability (95% fiducial limits)
-
8.8 (7.5-10.2)
- 95% Detection Probability (95% fiducial limits)
-
38.2 (32.0-47.3)
HIV-2 WHO (16/296)
- 50% Detection Probability (95% fiducial limits)
-
2.3 (1.9-2.6)
- 95% Detection Probability (95% fiducial limits)
-
9.5 (8.0-11.7)
HCV WHO (14/150)
- 50% Detection Probability (95% fiducial limits)
-
2.0 (1.7-2.3)
- 95% Detection Probability (95% fiducial limits)
-
9.6 (7.7-12.7)
HBV WHO (10/266)
- 50% Detection Probability (95% fiducial limits)
-
0.9 (0.7-1.0)
- 95% Detection Probability (95% fiducial limits)
-
3.1(2.7-3.9)
HEV WHO (6329/10)
- 50% Detection Probability (95% fiducial limits)
-
0.9 (0.7-1.0)
- 95% Detection Probability (95% fiducial limits)
-
3.6 (3.1-4.5)
| Panel tested | 50% Detection Probability (95% fiducial limits) | 95% Detection Probability (95% fiducial limits) |
|---|---|---|
|
HIV-1 WHO (16/194) |
8.8 (7.5-10.2) |
38.2 (32.0-47.3) |
|
HIV-2 WHO (16/296) |
2.3 (1.9-2.6) |
9.5 (8.0-11.7) |
|
HCV WHO (14/150) |
2.0 (1.7-2.3) |
9.6 (7.7-12.7) |
|
HBV WHO (10/266) |
0.9 (0.7-1.0) |
3.1(2.7-3.9) |
|
HEV WHO (6329/10) |
0.9 (0.7-1.0) |
3.6 (3.1-4.5) |
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