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Procleix WNV Assay (FDA Approved and CE Marked)
Ref. GRF-PROCLEIX-WNV-ASSAYSingle-tube, highly sensitive detection of the West Nile virus RNA in blood and plasma donations.
Tests per card
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Packaging
1000 or 5000 tests
Contact us for product availability and technical details.
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: 10,631; Specificity %: 100; 95% confidence interval: 99.965-100 |
| Specificity in normal blood donor plasma specimens - IDT (individual donation) | N: 13,371; Specificity %: 100; 95% 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