Procleix HEV Assay (CE Marked)
Single-tube, highly sensitive detection of the hepatitis E virus RNA in blood and plasma donations.
Assay Performance Characteristics*
Assay chemistry
- Procleix Panther system
-
Qualitative, transcription-mediated amplification (TMA)
Indication
- Procleix Panther system
-
Blood screening, source plasma, cadaveric (non-heart-beating) donors
Collection tube
- Procleix Panther system
-
Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples
Pool sizes
- Procleix Panther system
-
ID-NAT, 4, 8, 16
Assay kit size
- Procleix Panther system
-
1000 or 5000 tests
Detected virus
- Procleix Panther system
-
HEV (genotypes 1-4)***
| Platform | Procleix Panther system |
|---|---|
|
Assay chemistry |
Qualitative, transcription-mediated amplification (TMA) |
|
Indication |
Blood screening, source plasma, cadaveric (non-heart-beating) donors |
|
Collection tube |
Serum or plasma from EDTA, ACD, heparin or sodium citrate anti-coagulated samples |
|
Pool sizes |
ID-NAT, 4, 8, 16 |
|
Assay kit size |
1000 or 5000 tests |
|
Detected virus |
HEV (genotypes 1-4)*** |
Specificity in Fresh and Frozen Normal Blood Donor Plasma Specimens
4494
- Specificity %
-
99.98
- 95% confidence interval
-
99.87 - 100
| # of samples | Specificity % | 95% confidence interval |
|---|---|---|
|
4494 |
99.98 |
99.87 - 100 |
Analytical Sensitivity
Detection Probability (IU/mL)
HEV WHO international standard**
- 50% (95% fiducial limits)
-
2.02 (1.71 - 2.32)
- 95% (95% fiducial limits)
-
7.89 (6.63 - 9.83)
| Panel Tested | 50% (95% fiducial limits) | 95% (95% fiducial limits) |
|---|---|---|
|
HEV WHO international standard** |
2.02 (1.71 - 2.32) |
7.89 (6.63 - 9.83) |
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