ExtraStar® Purification Kit 2.0

 

5012045

 

The ExtraStar® Purification Kit 2.0 uses magnetic particle technology and is intended to be used for the automated isolation and purification of nucleic acids from human respiratory swab specimens for in vitro diagnostic purposes. The product is designed for use with the KingFisher™ Flex Purification System (Thermo Fisher Scientific) and altona Diagnostics kits and reagents specified for use with the ExtraStar® Purification Kit 2.0.

 

Product not licensed with Health Canada and not FDA cleared or approved. Kit not available in all countries.

Key features

  • Nucleic acids purification
  • Purification of 96 samples in 30 min
  • Using the KingFisher™ Flex Purification System (Thermo Fisher Scientific)

Sample types

The following sample type is validated for use with the ExtraStar® Purification Kit 2.0:

 

Human respiratory swabs in viral transport medium

Intended use

The ExtraStar® Purification Kit 2.0 uses magnetic particle technology and is intended to be used for the automated isolation and purification of nucleic acids from human respiratory swab specimens for in vitro diagnostic purposes. The product is designed for use with the KingFisher™ Flex Purification System (Thermo Fisher Scientific) and altona Diagnostics kits and reagents specified for use with the ExtraStar® Purification Kit 2.0.

Kit content

All reagents included in the ExtraStar® Purification Kit 2.0 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 has to be stored at +15 °C to +30 °C and

Box 2 has to be stored at +2 °C to +8 °C upon receipt.

 

The ExtraStar® Purification Kit 2.0 contains reagents sufficient for 384 sample purifications with a 300 µl sample volume.

ExtraStar® Purification Kit 2.0 – Content of Box 1

Box 1 ExtraStar® Purification Kit 2.0: This box contains 8 bottles, 2 bottle of each component. The Lysis Buffer contains chaotropic salts (guanidine thiocyanate,octoxynol 9) to disrupt cells or virions chemically. It stabilizes nucleic acids and protects them against nucleases in solution. The Wash Buffer 1 contains different salts and organic solvents (guanidine thiocyanate, ethanol) to remove proteins and other impurities. The Wash Buffer 2 contains organic solvents (ethanol) to remove proteins and other impurities. The Wash Buffer 3 contains different salts in order to purify the nucleic acids.

ExtraStar® Purification Kit 2.0 – Content of Box 2

Box 2 ExtraStar® Purification Kit 2.0: The Enhancer stabilizes and protects nucleic acids against nuclease in solution. The Magnetic Beads are coated with a thin layer of silica to bind nucleic acids in solution. The magnetic characteristic allows the separation of beads from liquids in magnetic field. The Elution Buffer is a low salt buffer to elute the nucleic acids from the magnetic beads for subsequent analysis.

ExtraStar® Purification Kit 2.0

Order No.5012045
Rxns384 (300 µl sample volume)
TransportationRoom temperature
Regulatory statusCE-IVD

ExtraStar® Purification Kit 2.0

Gebrauchsanweisung ExtraStar® Purification Kit 2.0

pdf
File size: 748.21 KB
Veröffentlichungsdatum: 12/2022
Regulatorischer Status: CE-IVD

Instructions for use ExtraStar® Purification Kit 2.0

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File size: 738.81 KB
Release date: 12/2022
Regulatory status: CE-IVD

Mode d’emploi ExtraStar® Purification Kit 2.0

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File size: 753.14 KB
Date de sortie: 12/2022
Statut réglementaire: CE-IVD

Instrucciones de uso ExtraStar® Purification Kit 2.0

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File size: 746.96 KB
Fecha de lanzamiento: 12/2022
Situación reglamentaria: CE-IVD

Instruções de utilização ExtraStar® Purification Kit 2.0

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File size: 760.28 KB
Data de lançamento: 12/2022
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso ExtraStar® Purification Kit 2.0

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File size: 743.39 KB
Data di rilascio: 12/2022
Stato normativo: CE-IVD

🇻🇳 Hướng dẫn sử dụng ExtraStar® Purification Kit 2.0

pdf
File size: 895.35 KB
Ngày ban hành: 12/2022
Tình trạng pháp lý: CE-IVD

🇵🇱 Instrukcja użytkowania ExtraStar® Purification Kit 2.0

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File size: 747.09 KB
Data wydania: 12/2022
Status prawny: CE-IVD

Principle of method

The ExtraStar® Purification Kit 2.0 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 KingFisherTM Flex Purification System (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.

ExtraStar® Purification Kit 2.0

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

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File size: 646.66 KB
Veröffentlichungsdatum/Release date/Date de sortie: 30.01.2023
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

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

pdf
File size: 668.33 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 30.01.2023
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD