AltoStar® Influenza Screen & Type RT-PCR Kit 1.5
AS0161543
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Influenza Screen & Type 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® Influenza Screen & Type RT-PCR Kit 1.5 
AltoStar® Influenza Screen & Type RT-PCR Kit 1.5
Products not FDA cleared or approved. Kits not available in all countries.
Key features
- Detection and differentiation of influenza A virus, influenza A (H1N1)pdm09 virus and influenza B virus specific RNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
Limit of detection (LoD)
| LoD influenza A virus |
370 copies/ml |
| LoD influenza A (H1N1)pdm09 virus | 241 copies/ml |
| LoD influenza B virus | 478 copies/ml |
Sample types
The following sample type is validated for use with the AltoStar® Influenza Screen & Type RT-PCR Kit 1.5:
Human respiratory swab specimens
Other workflows
The AltoStar® Influenza Screen & Type 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® Influenza Screen & Type 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® Influenza Screen & Type 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® Influenza Screen & Type RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of influenza A virus, influenza B virus and influenza A (H1N1)pdm09 virus specific RNA in human respiratory swab specimens. It is intended to be used as an aid for diagnosis of influenza A, influenza B and influenza A (H1N1)pdm09 virus infection.
AltoStar® Influenza Screen & Type RT-PCR Kit 1.5
| Order No. | AS0161543 |
| Rxns | 96 |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
AltoStar® Influenza S&T 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® Influenza S&T 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 |