Nat
Procleix UltrioPlex E Assay (CE Marked)
Ref. GRF-PROCLEIX-ULTRIOPLEX-E-ASSAYSingle-tube, highly sensitive detection of HEV RNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
Tests per card
—
Packaging
1000 or 5000 tests
Contact us for product availability and technical details.
About the Product
Single-tube, highly sensitive detection of HEV RNA, HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in blood and plasma donations.
The Procleix UltrioPlex E assay is CE Marked. This assay is not available for commercial sale in the US.
References: * Procleix UltrioPlex E assay package insert GDSS-IFU-000053-EN v. 2.0
Technical Characteristics
| Regulatory status | CE Marked |
|---|---|
| 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 |
| 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 |
| Specificity in fresh and frozen normal blood donor plasma specimens - HEV | # of samples: 7948; Specificity (%): 100; 95% confidence interval: 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) |
| Analytical sensitivity - 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) |
| Analytical sensitivity - 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) |
| Analytical sensitivity - 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) |
| Analytical sensitivity - 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) |
Technical Information
No technical information available for this product.
Compatibility
Platform: Procleix Panther system
Packaging
1000 or 5000 tests