Procleix WNV Assay (FDA Approved and CE Marked)
Procleix Assays

Procleix WNV Assay (FDA Approved and CE Marked)

Ref. GRF-PROCLEIX-WNV-ASSAY

Single-tube, highly sensitive detection of the West Nile virus RNA 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 the West Nile virus RNA in blood and plasma donations.

The Procleix WNV assay is CE marked and FDA approved.

References: *Procleix WNV assay on Procleix Panther system package insert, WNV-8.0-IFU-en

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 from K2EDTA, K3EDTA, ACD, heparin, or sodium citrate anti-coagulated tubes
Pool sizes IDT-NAT, pools of 4, 8, or 16
Detected virus WNV lineage 1 & 2
Specificity in normal blood donor plasma specimens - 16-sample pool N: 10,631Specificity %: 10095% confidence interval: 99.965-100
Specificity in normal blood donor plasma specimens - IDT (individual donation) N: 13,371Specificity %: 10095% confidence interval: 99.972-100
Analytical sensitivity, detection probabilities (copies/mL) - Health Canada reference standard
  • 50% (95% fiducial limits): 2.0 (1.6-2.4)
  • 95% (95% fiducial limits): 11.9 (9.6-15.9)
Analytical sensitivity, detection probabilities (copies/mL) - WNV Lineage 1 IVT
  • 50% (95% fiducial limits): 2.8 (2.3-3.2)
  • 95% (95% fiducial limits): 12.9 (10.6-16.7)
Analytical sensitivity, detection probabilities (copies/mL) - WNV Lineage 2 IVT
  • 50% (95% fiducial limits): 3.1 (2.7-3.6)
  • 95% (95% fiducial limits): 12.0 (10.0-15.2)

Technical Information

No technical information available for this product.

Compatibility

Platform: Procleix Panther or Procleix Panther ART system

Packaging

1000 or 5000 tests