Procleix Ultrio Elite Assay (FDA Approved and CE Marked)
Procleix Assays

Procleix Ultrio Elite Assay (FDA Approved and CE Marked)

Ref. GRF-PROCLEIX-ULTRIO-ELITE-ASSAY

Single-tube, highly sensitive detection of 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 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.

Technical Characteristics

Regulatory status FDA Approved and CE Marked
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
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

Technical Information

No technical information available for this product.

Compatibility

Platform: Procleix Panther system

Packaging

1000 or 5000 tests