AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

 

IVD 2022 (AS0821543/AS0821547)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® SARS-CoV-2 RT-PCR kits have received a new product number and Global Trade Item Number (GTIN). The new product numbers reflect the desired change in regulatory status. All other product characteristics as well as the product performances remain unchanged. The kits are chemically identical to their already existing counterparts and contain the same kit components.

The assay is available in two different configurations!

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Key features

  • Detection of lineage B-betacoronavirus (B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in PFU/ml

Limit of detection (LoD)

LoD E gene
0.025 PFU/ml
LoD S gene
0.014 PFU/ml

 

Sample types

The following sample type is validated for use with the AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

 

Human respiratory swab specimens

Other workflows

The AltoStar® SARS-CoV-2 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® SARS-CoV-2 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® SARS-CoV-2 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® SARS-CoV-2 RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA in human respiratory swab specimens. It is intended to be used as an aid for diagnosis of SARS-CoV-2 infection.

AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

Order No.AS0821543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

Order No.AS0821547
Rxns1200
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

Gebrauchsanweisung AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

pdf
File size: 3.41 MB
Veröffentlichungsdatum: 10/2021
Regulatorischer Status: CE-IVD

Gebrauchsanweisung AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

pdf
File size: 3.41 MB
Veröffentlichungsdatum: 10/2021
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

pdf
File size: 3.25 MB
Release date: 10/2021
Regulatory status: CE-IVD

Instructions for use AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

pdf
File size: 3.25 MB
Release date: 10/2021
Regulatory status: CE-IVD

Mode d'emploi AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

pdf
File size: 3.23 MB
Date de sortie: 10/2021
Statut réglementaire: CE-IVD

Mode d'emploi AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

pdf
File size: 3.23 MB
Date de sortie: 10/2021
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

pdf
File size: 3.72 MB
Fecha de lanzamiento: 10/2021
Situación reglamentaria: CE-IVD

Instrucciones de uso AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

pdf
File size: 3.41 MB
Fecha de lanzamiento: 10/2021
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

pdf
File size: 3.43 MB
Data de lançamento: 10/2021
Estatuto regulamentar: CE-IVD

Instruções de Utilização AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

pdf
File size: 3.42 MB
Data de lançamento: 10/2021
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

pdf
File size: 3.21 MB
Data di rilascio: 10/2021
Stato normativo: CE-IVD

Istruzioni per l'uso AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

pdf
File size: 3.21 MB
Data di rilascio: 10/2021
Stato normativo: CE-IVD

AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

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

pdf
File size: 538.51 KB
Veröffentlichungsdatum/Release date/Date de sortie: 26.11.2021
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)

pdf
File size: 550.75 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 26.11.2021
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD

AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns)

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

pdf
File size: 533.15 KB
Veröffentlichungsdatum/Release date/Date de sortie: 26.11.2021
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)

pdf
File size: 550.93 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 26.11.2021
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD