AltoStar® Purification Kit 1.5

 

IVD 2022 (PK15-46)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Purification Kit 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 except the whole blood pretreatment buffer. This buffer will be available as a stand-alone product under the product name AltoStar® Whole Blood Pretreatment Buffer 1.5 (Order No. WBPB15-46).

AltoStar® Purification Kit 1.5 – Delivery of two boxes

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

Key features

  • DNA and RNA purification in parallel
  • All sample types in one run
  • Analyze up to four pathogens from a single sample

Sample types

The following sample types are validated for use with the AltoStar® Purification Kit 1.5:

 

Human EDTA and citrate whole blood

Human serum

Human EDTA and citrate plasma

Human urine

Human stool

Human cerebrospinal fluid (CSF)

Human swabs in viral transport medium

Intended use

The AltoStar® Purification Kit 1.5 uses magnetic particle technology and is intended to be used for the automated isolation and purification of nucleic acids from specified human specimens for in vitro diagnostic purposes. The product is designed for use with the AltoStar® Automation System AM16, the AltoStar® Internal Control 1.5 and altona Diagnostics kits and reagents specified for use with the AltoStar® Purification Kit 1.5.

Kit content

All reagents included in the AltoStar® Purification Kit 1.5 are ready-to-use solutions and are shipped in two separate boxes: Box 1 and Box 2. The boxes are shipped at room temperature.

 

Box 1 (with 5 different boxes inside) has to be stored at +15 °C to +30 °C and

Box 2 (with 6 trays inside) has to be stored at +2 °C to +8 °C upon receipt.

 

The AltoStar® Purification Kit 1.5 contains reagents sufficient for 1152 sample purifications with a 500 µl sample volume, or for 576 sample purifications with a 1000 µl sample volume.

AltoStar® Purification Kit 1.5 – Content of Box 1
(with 5 different boxes inside)

AltoStar® Purification Kit 1.5 – Content of Box 2
(6 trays with tubes inside)

AltoStar® Purification Kit 1.5

Order No.PK15-46
Sample purifications1152 (500 µl sample volume, low volume) or 576 (1000 µl sample volume, high volume)
TransportationRoom temperature
Regulatory statusCE-IVD

AltoStar® Purification Kit 1.5

Gebrauchsanweisung AltoStar® Purification Kit 1.5

pdf
File size: 2.95 MB
Veröffentlichungsdatum: 04/2022
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® Purification Kit 1.5

pdf
File size: 3.29 MB
Release date: 04/2022
Regulatory status: CE-IVD

Mode d’emploi AltoStar® Purification Kit 1.5

pdf
File size: 3.14 MB
Date de sortie: 04/2022
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® Purification Kit 1.5

pdf
File size: 3.14 MB
Fecha de lanzamiento: 04/2022
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® Purification Kit 1.5

pdf
File size: 3.14 MB
Data de lançamento: 04/2022
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® Purification Kit 1.5

pdf
File size: 3.13 MB
Data di rilascio: 04/2022
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 human specimens for in vitro diagnostic purposes in conjunction with the AltoStar® AM16, the AltoStar® Internal Control 1.5, as well as with the altona Diagnostics kits and reagents, which are 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 Fig.).

 

 

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® Purification Kit 1.5

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

pdf
File size: 667.14 KB
Veröffentlichungsdatum/Release date/Date de sortie: 24.05.2022
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)

pdf
File size: 680.90 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 24.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD