AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
The AltoStar® PCR Kits 1.5 are developed for the simultaneous testing of pathogens by harmonized cycling conditions and enabling the identification of clinical pathogens using the AltoStar® Molecular Diagnostic Workflow.
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 respiratory swab specimens. 
The AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 consists of: Two Master reagents (Master A and Master B), Positive Control and a No Template Control (NTC).
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
- Ready-to-use kit including positive control for both targets, B-βCoV and SARS-CoV-2
- Analytical sensitivity reported in PFU/ml
- Mixed batches possible: all sample types in parallel
- Simultaneous processing: up to 8 assays in the same run
- Compatible with AltoStar® Automation System AM16
- CE-IVD marked in vitro diagnostic test
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 respiratory swab specimens. It is configured for use with the CFX96™ Deep Well Dx System (Bio-Rad) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5.
The AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 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. | AS0821513 |
| Rxns | 96 |
| Sample Types | Respiratory swab specimens |
| Transportation | Dry ice |
| For use with | AltoStar® Automation System AM16 / AltoStar® Connect Software AltoStar® Purification Kit 1.5 AltoStar® Internal Control 1.5 CFX96™ Deep Well Dx System |
The results generated with the AltoStar® SARS-CoV-2 PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® SARS-CoV-2 PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Konformitätserklärung/Declaration of Conformity/Déclaration de conformité - DE, EN, FR
pdf| Veröffentlichungsdatum/Release date/Date de sortie: | 10.12.2020 |
| Filesize: | 291.43 KB |
Declaración de conformidad/Dichiarazione di Conformità/Declaração de conformidade - ES, IT, PT
pdf| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 10.12.2020 |
| Filesize: | 298.88 KB |