Intended use
The AltoStar® Norovirus RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of norovirus genogroup I (GI) and II (GII) specific RNA in human stool samples. It is intended to be used as an aid for diagnosis of norovirus infection.
| LoD norovirus GI | 1,583 copies/ml |
| LoD norovirus GII | 644 copies/ml |
The following sample type is validated for use with the AltoStar® Norovirus RT-PCR Kit 1.5:
Human stool
The AltoStar® Norovirus 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® Norovirus 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® Norovirus 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.
In the course of the of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Norovirus RT-PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.
Products not FDA cleared or approved. Kits not available in all countries.
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altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany