Description
Intended use
The AltoStar® HAV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of hepatitis A virus (HAV) specific RNA in human plasma. It is intended to be used as an aid for diagnosis of HAV infection.
Specifications
Key features
- Qualitative detection of hepatitis A virus (HAV) specific RNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD plasma | 6.31 IU/ml |
Sample types
The following sample types are validated for use with the AltoStar® HAV RT-PCR Kit 1.5:
- Human EDTA plasma
- Human citrate plasma
Other workflows
The AltoStar® HAV RT-PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar® HAV RT-PCR Kit 1.5 are:
- CFX96™ Deep Well Dx System (Bio-Rad)
- CFX96™ Dx System (Bio-Rad)
- ABI Prism® 7500 SDS (Applied Biosystems)
- LightCycler® 480 Instrument II (Roche)
- QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)
- Rotor-Gene® Q5/6 plex Platform (QIAGEN)
The AltoStar® HAV RT-PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.
