AltoStar® Norovirus RT-PCR Kit 1.5
AS0051543
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.
AltoStar® Norovirus RT-PCR Kit 1.5 
AltoStar® Norovirus RT-PCR Kit 1.5
Products not FDA cleared or approved. Kits not available in all countries.
Key features
- Detection and differentiation of norovirus genogroup I (GI) and norovirus genogroup II (GII) specific RNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
Limit of detection (LoD)
| LoD norovirus GI |
1,583 copies/ml |
| LoD norovirus GII | 644 copies/ml |
Sample types
The following sample type is validated for use with the AltoStar® Norovirus RT-PCR Kit 1.5:
Human stool
Other workflows
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.
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.
AltoStar® Norovirus RT-PCR Kit 1.5
| Order No. | AS0051543 |
| Rxns | 96 |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
AltoStar® Norovirus RT-PCR Kit 1.5
| Veröffentlichungsdatum: | 04/2022 |
| Regulatorischer Status: | CE-IVD |
| Release date: | 04/2022 |
| Regulatory status: | CE-IVD |
| Date de sortie: | 04/2022 |
| Statut réglementaire: | CE-IVD |
| Fecha de lanzamiento: | 04/2022 |
| Situación reglamentaria: | CE-IVD |
| Data de lançamento: | 04/2022 |
| Estatuto regulamentar: | CE-IVD |
| Data di rilascio: | 04/2022 |
| Stato normativo: | CE-IVD |
| Ngày ban hành: | 04/2022 |
| Tình trạng pháp lý: | CE-IVD |
AltoStar® Norovirus RT-PCR Kit 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdf| Veröffentlichungsdatum/Release date/ Date de sortie: | 18.05.2022 |
| Regulatorischer Status/Regulatory status/Statut réglementaire: | CE-IVD |
Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)
pdf| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
| Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |