Procleix Assays
Procleix HEV Assay (CE Marked)
Ref. GRF-PROCLEIX-HEV-ASSAYSingle-tube, highly sensitive detection of the hepatitis E virus RNA in blood and plasma donations.
Tests per card
—
Packaging
1000 or 5000 tests
Contact us for product availability and technical details.
About the Product
Single-tube, highly sensitive detection of the hepatitis E virus RNA in blood and plasma donations.
The Procleix HEV assay is CE marked. This assay is not available for commercial sale in the US.
References: Procleix HEV assay package insert, HEV-2.0-IFU-en
** PEI code: 6329/10
*** HEV1, HEV2, HEV3a, HEV3b, HEV3c, HEV3f, and HEV4c
Technical Characteristics
| Regulatory status | 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 EDTA, ACD, heparin or sodium citrate anti-coagulated samples |
| Pool sizes | ID-NAT, 4, 8, 16 |
| Detected virus | HEV (genotypes 1-4)*** |
| Specificity in fresh and frozen normal blood donor plasma specimens | # of samples: 4494Specificity %: 99.9895% confidence interval: 99.87 - 100 |
| Analytical sensitivity, detection probability (IU/mL) - HEV WHO international standard** |
|
Technical Information
No technical information available for this product.
Compatibility
Platform: Procleix Panther system
Packaging
1000 or 5000 tests