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.
| LoD plasma | 6.31 IU/ml |
The following sample types are validated for use with the AltoStar® HAV RT-PCR Kit 1.5:
Human EDTA plasma
Human citrate plasma
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.
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
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altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany