AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

 

IVD 2022 (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.

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
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® Influenza S&T RT-PCR Kit 1.5

Gebrauchsanweisung AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

pdf
File size: 3.40 MB
Veröffentlichungsdatum: 04/2022
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

pdf
File size: 3.35 MB
Release date: 04/2022
Regulatory status: CE-IVD

Mode d'emploi AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

pdf
File size: 3.43 MB
Date de sortie: 04/2022
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

pdf
File size: 3.10 MB
Fecha de lanzamiento: 04/2022
Situación reglamentaria: CE-IVD

Instruções de utilização AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

pdf
File size: 3.42 MB
Data de lançamento: 04/2022
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® Influenza Screen & Type RT-PCR Kit 1.5

pdf
File size: 3.41 MB
Data di rilascio: 04/2022
Stato normativo: CE-IVD

AltoStar® Influenza S&T RT-PCR Kit 1.5

Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)

pdf
File size: 528.81 KB
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
File size: 535.55 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD