Procleix WNV Assay (FDA Approved and CE Marked)
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.
Assay Performance Characteristics*
Assay chemistry
- Procleix Panther or Procleix Panther ART system
-
Qualitative, transcription-mediated amplification (TMA)
Indication
- Procleix Panther or Procleix Panther ART system
-
Blood screening, source plasma, cadaveric (non-heart-beating) donors
Collection tube
- Procleix Panther or Procleix Panther ART system
-
Serum or plasma from K2EDTA, K3EDTA, ACD, heparin, or sodium citrate anti-coagulated tubes
Pool sizes
- Procleix Panther or Procleix Panther ART system
-
IDT-NAT, pools of 4, 8, or 16
Assay kit size
- Procleix Panther or Procleix Panther ART system
-
1000 or 5000 tests
Detected virus
- Procleix Panther or Procleix Panther ART system
-
WNV lineage 1 & 2
| Platform | Procleix Panther or Procleix Panther ART system |
|---|---|
|
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 |
|
Assay kit size |
1000 or 5000 tests |
|
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
IDT (individual donation)
- N
-
13,371
- Specificity %
-
100
- 95% confidence interval
-
99.972-100
| Sample Type | N | Specificity % | 95% confidence interval |
|---|---|---|---|
|
16-sample pool |
10,631 |
100 |
99.965-100 |
|
IDT (individual donation) |
13,371 |
100 |
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)
WNV Lineage 1 IVT
- 50% (95% fiducial limits)
-
2.8 (2.3-3.2)
- 95% (95% fiducial limits)
-
12.9 (10.6-16.7)
WNV Lineage 2 IVT
- 50% (95% fiducial limits)
-
3.1 (2.7-3.6)
- 95% (95% fiducial limits)
-
12.0 (10.0-15.2)
| Panel tested | 50% (95% fiducial limits) | 95% (95% fiducial limits) |
|---|---|---|
|
Health Canada reference standard |
2.0 (1.6-2.4) |
11.9 (9.6-15.9) |
|
WNV Lineage 1 IVT |
2.8 (2.3-3.2) |
12.9 (10.6-16.7) |
|
WNV Lineage 2 IVT |
3.1 (2.7-3.6) |
12.0 (10.0-15.2) |
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