Procleix UltrioPlex E Assay (CE Marked)
Procleix Assays

Procleix UltrioPlex E Assay (CE Marked)

Ref. GRF-PROCLEIX-ULTRIOPLEX-E-ASSAY

Single-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
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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: 7948Specificity (%): 10095% confidence interval: 99.95 - 100
Specificity in fresh and frozen normal blood donor plasma specimens - HEV # of samples: 7948Specificity (%): 10095% 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