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 pathogen 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.

 

Product not licensed with Health Canada and not FDA cleared or approved. Kit 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
  • Ready-to-use kit including Quantification Standards
  • Dual target detection: with amplification of separate regions of HIV-1 genome
  • Targets detected: Target 1 = integrase (INT), target 2 = protease (PRO)
  • Quantification Standards calibrated against the 4th WHO International Standard for HIV-1 RNA (NIBSC code: 16/194)
  • Analytical sensitivity reported in IU/ml
  • CE-IVD marked in vitro diagnostic test

Intended use

 

The AltoStar® HIV RT-PCR Kit 1.5 is an automated in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human immunodeficiency virus (HIV) specific RNA (groups M, N and O) 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.

AltoStar® HIV RT-PCR Kit 1.5

Order No.AS0221513
Rxns96
Sample typesHuman EDTA plasma
TransportationDry ice
For use withAltoStar® Automation System AM16 / AltoStar® Connect software
AltoStar® Purification Kit 1.5
AltoStar® Internal Control 1.5
CFX96™ Deep Well Dx System

The AltoStar® HIV RT-PCR Kit 1.5 is intended to be used for viral load monitoring in HIV infection. The results generated with the AltoStar® HIV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HIV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.

AltoStar® HIV RT-PCR Kit 1.5

Instructions for Use AltoStar® HIV RT-PCR Kit 1.5

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Release Date: 09/2020
Filesize: 5.05 MB

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

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Date de sortie: 09/2020
Filesize: 5.65 MB

Instrucciones de uso AltoStar® HIV RT-PCR Kit 1.5

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Fecha de lanzamiento: 09/2020
Filesize: 5.65 MB

Instruções de Utilização AltoStar® HIV RT-PCR Kit 1.5

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Data de lançamento: 09/2020
Filesize: 5.69 MB

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

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Data di rilascio: 09/2020
Filesize: 5.52 MB

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 AM 16 platform

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Poster: ESCV 2021
Filesize: 333.39 KB

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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Veröffentlichkeitsdatum: 05.11.2021
Filesize: 746.70 KB

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

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Veröffentlichkeitsdatum: 03.02.2021
Filesize: 459.37 KB

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

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Release Date: 05.11.2021
Filesize: 1.24 MB

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

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Release Date: 03.02.2021
Filesize: 442.84 KB

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

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Date de sortie: 05.11.2021
Filesize: 1.44 MB

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

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Date de sortie: 03.02.2021
Filesize: 442.68 KB

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

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Fecha de lanzamiento: 05.11.2021
Filesize: 1.15 MB

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

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Fecha de lanzamiento: 03.02.2021
Filesize: 359.84 KB

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

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Data de lançamento: 05.11.2021
Filesize: 1.25 MB

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

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Data de lançamento: 03.02.2021
Filesize: 432.62 KB

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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Data di uscita: 05.11.2021
Filesize: 1.44 MB

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

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Data di uscita: 03.02.2021
Filesize: 462.00 KB

AltoStar® HIV RT-PCR Kit 1.5

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

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Veröffentlichungsdatum/Release date/ Date de sortie: 24.03.2021
Filesize: 555.73 KB

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

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Fecha de lanzamiento/Data di rilascio/Data de lançamento: 24.03.2021
Filesize: 578.93 KB

Info-Flyer AltoStar® HIV RT-PCR Kit 1.5

Automated testing for HIV and Hepatitis B and C Virus

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Release date: 11/2021
Filesize: 1.70 MB

Automated real-time PCR testing for HIV

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Release Date: 09/2021
Filesize: 1.99 MB