AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
AS0821543 / AS0821547
In the course of the 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!


AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 AltoStar® SARS-CoV-2 RT-PCR Kit 1.5: Configuration 1200 reactions
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 |
Rxns | 96 |
Transportation | Dry ice |
Regulatory status | CE-IVD |
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Order No. | AS0821547 |
Rxns | 1200 |
Transportation | Dry ice |
Regulatory status | CE-IVD |
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Veröffentlichungsdatum: | 10/2021 |
Regulatorischer Status: | CE-IVD |
Veröffentlichungsdatum: | 10/2021 |
Regulatorischer Status: | CE-IVD |
Release date: | 10/2021 |
Regulatory status: | CE-IVD |
Release date: | 10/2021 |
Regulatory status: | CE-IVD |
Date de sortie: | 10/2021 |
Statut réglementaire: | CE-IVD |
Date de sortie: | 10/2021 |
Statut réglementaire: | CE-IVD |
Fecha de lanzamiento: | 10/2021 |
Situación reglamentaria: | CE-IVD |
Fecha de lanzamiento: | 10/2021 |
Situación reglamentaria: | CE-IVD |
Data de lançamento: | 10/2021 |
Estatuto regulamentar: | CE-IVD |
Data de lançamento: | 10/2021 |
Estatuto regulamentar: | CE-IVD |
Data di rilascio: | 10/2021 |
Stato normativo: | CE-IVD |
Data di rilascio: | 10/2021 |
Stato normativo: | CE-IVD |
Data wydania: | 10/2021 |
Status prawny: | CE-IVD |
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdfVeröffentlichungsdatum/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)
pdfFecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
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)
pdfVeröffentlichungsdatum/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)
pdfFecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |