AltoStar® HIV 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 pathogens using the AltoStar® Molecular Diagnostic Workflow. The AltoStar® HIV RT-PCR Kit 1.5 is designed as a dual target assay for reliable viral load monitoring of HIV infected patients.

 

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

Key features

  • Detection and quantification of human immunodeficiency virus type 1 (HIV-1) specific RNA
  • Detection of group M, N and O in human EDTA plasma
  • Quantification Standards calibrated against the 4th WHO International Standard for HIV-1 RNA (NIBSC code: 16/194)
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD human EDTA plasma
30.0 IU/ml

 

Sample types

The following sample type is validated for use with the AltoStar® HIV RT-PCR Kit 1.5:

 

Human EDTA plasma

Intended use

The AltoStar® HIV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human immunodeficiency virus type 1 (HIV-1) specific RNA in human EDTA plasma. 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® HIV RT-PCR Kit 1.5 is intended to be used for viral load monitoring in HIV infection.

AltoStar® HIV RT-PCR Kit 1.5

Order No.AS0221513
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® HIV RT-PCR Kit 1.5

Gebrauchsanweisung AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.53 MB
Veröffentlichungsdatum: 02/2022

Instructions for use AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.44 MB
Release date: 02/2022

Mode d'emploi AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.57 MB
Date de sortie: 02/2022

Instrucciones de uso AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.55 MB
Fecha de lanzamiento: 02/2022

Instruções de utilização AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.56 MB
Data de lançamento: 02/2022

Istruzioni per l'uso AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.55 MB
Data di rilascio: 02/2022

🇵🇱 Instrukcja użytkowaniao AltoStar® HIV RT-PCR Kit 1.5

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File size: 2.58 MB
Data wydania: 02/2022

References AltoStar® HIV RT-PCR Kit 1.5

Performance evaluation of the novel AltoStar® HIV RT-PCR Kit 1.5 on the fully automated AltoStar® Automation System AM16 platform

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File size: 333.39 KB
Poster: ESCV 2021

AltoStar® HIV RT-PCR Kit 1.5 - Certificates

AltoStar® HIV RT-PCR Kit 1.5 - EG-Zertifikat-QM-System_CMV-HCV-HBV-HIV (DE)

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File size: 746.63 KB
Veröffentlichungsdatum: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - EG-Zertifikat-Auslegungsprüfbescheinigung_HIV (DE)

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File size: 451.51 KB
Veröffentlichungsdatum: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificate_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (EN)

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File size: 1.24 MB
Release date: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - EC Design Examination Certificate_HIV (EN)

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File size: 705.36 KB
Release date: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificat_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (FR)

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File size: 1.43 MB
Date de sortie: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificat d'examen CE de la conception_HIV (FR)

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File size: 705.15 KB
Date de sortie: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (ES)

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File size: 1.15 MB
Fecha de lanzamiento: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificado de examen CE del diseño_HIV (ES)

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File size: 609.48 KB
Fecha de lanzamiento: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (PT)

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File size: 1.25 MB
Data de lançamento: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificado de exame CE de concepção_HIV (PT)

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File size: 695.76 KB
Data de lançamento: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 -Certificate_Sistema di qualita_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (IT)

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File size: 1.43 MB
Data di rilascio: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5 - Certificato di esame CE della progettazione_HIV (IT)

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File size: 724.51 KB
Data di rilascio: 13.05.2022

AltoStar® HIV RT-PCR Kit 1.5

Konformitätserklärung/Declaration of Conformity/Déclaration de conformité - DE, EN, FR

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File size: 532.74 KB
Veröffentlichungsdatum/Release date/Date de sortie: 18.05.2022

Declaración de conformidad/Dichiarazione di Conformità/Declaração de conformidade - ES, IT, PT

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File size: 542.56 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022

Info flyer AltoStar® HIV RT-PCR Kit 1.5

Automated testing for HIV-1 and Hepatitis B and C Virus

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File size: 1.38 MB
Release date: 03/2023

Automated real-time PCR testing for HIV-1

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File size: 1.66 MB
Release date: 03/2023