AltoStar® HBV PCR Kit 1.5
| Order No | AS0201513 |
| Rxns | 96 |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
The AltoStar® HBV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis B virus (HBV) specific DNA (genotypes A to H) in human EDTA plasma.
The AltoStar® HBV PCR Kit 1.5 is configured for use with the CFX96™ Deep Well Dx System (Bio-Rad) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5.
The AltoStar® HBV PCR Kit 1.5 is intended to be used for viral load monitoring in individuals with HBV infection.
Specifications
Key features
- Detection and quantification of hepatitis B virus (HBV) specific DNA
- Detection of genotypes A to H in human EDTA plasma
- Quantification Standards calibrated against the 4th WHO International Standard for HBV DNA for nucleic acid amplification techniques (NIBSC code: 10/266)
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD human EDTA plasma | 10.2 IU/ml |
Sample types
The following sample type is validated for use with the AltoStar® HBV PCR Kit 1.5:
Human EDTA plasma
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