AltoStar® HCV RT-PCR Kit 1.5
The AltoStar® RT-PCR Kits 1.5 are developed for the simultaneous testing of pathogens by harmonized cycling conditions and enabling the identification of clinical pathogen using the AltoStar® Molecular Diagnostic Workflow.

AltoStar® HCV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of hepatitis C virus (HCV) specific RNA (genotypes 1 to 6) in human EDTA plasma. The AltoStar® HCV RT-PCR Kit 1.5 consists of: Two Master reagents (Master A and Master B), Four Quantification Standards (QS1 - QS4) 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 and quantification of hepatitis C virus (HCV) specific RNA
- Detection of genotypes 1 to 6 in human EDTA plasma
- Ready-to-use Kit including Quantification Standards
- Quantification Standards calibrated against the 5th WHO International Standard for HCV NAT (NIBSC code: 14/150)
- Analytical sensitivity reported in IU/ml
- Mixed batches possible: all sample types in parallel
- Simultaneous processing: up to 8 assays in the same run
- CE-IVD marked in vitro Diagnostic Test
Intended Use
The AltoStar® HCV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis C virus (HCV) specific RNA (genotypes 1 to 6) in human EDTA plasma. The AltoStar® HCV RT-PCR Kit 1.5 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.
AltoStar® HCV RT-PCR Kit 1.5
Order No. | AS0211513 |
Rxns | 96 |
Sample Types | Human EDTA plasma |
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® HCV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HCV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.
References AltoStar® HCV RT-PCR Kit 1.5
Performance evaluation of the novel AltoStar® HCV RT-PCR Kit 1.5 on the fully automated AltoStar®System
pdfPoster: | ESCV 2019 |
Filesize: | 416.82 KB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificates
AltoStar® HCV RT-PCR Kit 1.5 - EG-Zertifikat-QM-System_CMV-HCV (DE)
pdfVeröffentlichkeitsdatum: | 07.07.2020 |
Filesize: | 776.03 KB |
AltoStar® HCV RT-PCR Kit 1.5 - EG-Zertifikat-Auslegungsprüfbescheinigung_HCV (DE)
pdfVeröffentlichkeitsdatum: | 06.12.2018 |
Filesize: | 231.23 KB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificate_Annex IV 98-79 CE_CMV_HCV (EN)
pdfRelease Date: | 07.07.2020 |
Filesize: | 1.30 MB |
AltoStar® HCV RT-PCR Kit 1.5 - EC Design Examination Certificate_HCV (EN)
pdfRelease Date: | 06.12.2018 |
Filesize: | 231.98 KB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificat_Annex IV 98-79 CE_CMV_HCV (FR)
pdfDate de sortie: | 07.07.2020 |
Filesize: | 1.49 MB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificat d'examen CE de la conception_HCV (FR)
pdfDate de sortie: | 06.12.2018 |
Filesize: | 231.04 KB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV_HCV (ES)
pdfFecha de lanzamiento: | 07.07.2020 |
Filesize: | 1.21 MB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificado de examen CE del diseño_HCV (ES)
pdfFecha de lanzamiento: | 06.12.2018 |
Filesize: | 232.12 KB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV_HCV (PT)
pdfData de lançamento: | 07.07.2020 |
Filesize: | 1.31 MB |
AltoStar® HCV RT-PCR Kit 1.5 - Certificado de exame CE de concepcao_HCV (PT)
pdfData de lançamento: | 06.12.2018 |
Filesize: | 228.80 KB |
AltoStar® HCV RT-PCR Kit 1.5 -Certificate_Sistema di qualita_Annex IV 98-79 CE CMV-HCV-HBV (IT)
pdfData di uscita: | 07.07.2020 |
Filesize: | 1.51 MB |
AltoStar® HCV RT-PCR Kit 1.5
Konformitätserklärung/Declaration of Conformity/Déclaration de conformité - DE, EN, FR
pdfVeröffentlichungsdatum/Release date/ Date de sortie: | 21.02.2020 |
Filesize: | 551.99 KB |
Declaración de conformidad/Dichiarazione di Conformità/Declaração de conformidade - ES, IT, PT
pdfFecha de lanzamiento/Data di rilascio/Data de lançamento: | 21.02.2020 |
Filesize: | 567.93 KB |