AltoStar® Internal Control 1.5

 

IVD 2022 (IC15-46)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Internal Control 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.

 

Products not FDA cleared or approved. Kits not available in all countries.

Key features

  • One universal internal control (sample, extraction, PCR)
  • Contains a defined copy number of DNA and RNA template molecules with different sequences of artificial origin
  • Automatically added at the beginning of the nucleic acid purification procedure
  • Serves as a process control for purification and/or real-time (RT-)PCR
  • Performance is verified in conjunction with each altona Diagnostics kit specified for use with the AltoStar®
    Internal Control 1.5
  • Lot checking and expiry date checking

Intended use

The AltoStar® Internal Control 1.5 is intended to be used as a nucleic acid purification, amplification and detection control for in vitro diagnostic purposes. It is designed for use with the AltoStar® Purification Kit 1.5 and altona Diagnostics kits and reagents specified for use with the AltoStar® Internal Control 1.5.

Kit content

The AltoStar® Internal Control 1.5 box contains 24 tubes and is shipped on dry ice. After receipt the AltoStar® Internal Control 1.5 must be stored at -25 °C to -15 °C.

 

Each IC (internal control) tube contains sufficient volume to perform 48 nucleic acid purifications with the AltoStar® Purification Kit 1.5.

AltoStar® Internal Control 1.5

Order No.IC15-46
Rxns1,152 (500 µl sample volume, low volume) or 576 (1,000 µl sample volume, high volume)
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® Internal Control 1.5

Gebrauchsanweisung AltoStar® Internal Control 1.5

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File size: 279.47 KB
Veröffentlichungsdatum: 10/2021
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® Internal Control 1.5

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File size: 313.53 KB
Release date: 10/2021
Regulatory status: CE-IVD

Mode d’emploi AltoStar® Internal Control 1.5

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File size: 320.43 KB
Date de sortie: 10/2021
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® Internal Control 1.5

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File size: 314.90 KB
Fecha de lanzamiento: 10/2021
Situación reglamentaria: CE-IVD

Instruções de utilização AltoStar® Internal Control 1.5

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File size: 317.93 KB
Data de lançamento: 10/2021
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® Internal Control 1.5

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File size: 310.02 KB
Data di rilascio: 10/2021
Stato normativo: CE-IVD

Principle of method

The AltoStar® Purification Kit 1.5 is intended for automated isolation and purification of RNA and DNA from specified biological specimens for in vitro diagnostic purposes in conjunction with the AltoStar® AM16, the AltoStar® Internal Control 1.5 and altona Diagnostics kits and reagents specified for use with the AltoStar® Purification Kit 1.5. The AltoStar® Purification Kit 1.5 is based on magnetic bead technology, utilizing silica-coated magnetic particles, which can bind and release nucleic acids under specific conditions.

 

The purification procedure comprises 3 automated steps on the AltoStar® AM16 (see figure).

 

 

Sample lysis and DNA/RNA binding

1. In the first step nucleic acids are released by chemical and mechanical lysis under chaotropic high salt conditions. The conditions stabilize the nucleic acids in solution and enable their binding to the magnetic silica beads. The AltoStar® Internal Control 1.5 is automatically added by the AltoStar® AM16.

AltoStar® Internal Control 1.5

Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)

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File size: 517.72 KB
Veröffentlichungsdatum/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)

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File size: 530.56 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD