AltoStar® Purification Kit 1.5
PK15-46
In the course of the 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
The AltoStar® Purification Kit 1.5 is a nucleic acid isolation and purification kit. It permits the simultaneous purification of RNA and DNA from multiple sample types on the AltoStar® Automation System AM16. 
AltoStar® Purification Kit 1.5 – Box 1 and content 
AltoStar® Purification Kit 1.5 – Box 2
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 1,152 sample purifications with a 500 µl sample volume, or for 576 sample purifications with a 1,000 µl sample volume.
AltoStar® Purification Kit 1.5 – Content of Box 1
(with 5 different boxes inside)
Box 1 AltoStar® Purification Kit 1.5: 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 (6 x containers, Box 1/5). 
Box 1 AltoStar® Purification Kit 1.5: The Wash Buffer 1 contains different salts and organic solvents (guanidine thiocyanate, ethanol) to remove proteins and other impurities (6 x container, Box 2/5). 
Box 1 AltoStar® Purification Kit 1.5: The Wash Buffer 2 contains organic solvents (ethanol) to remove proteins and other impurities (6 x container, Box 3/5). 
Box 1 AltoStar® Purification Kit 1.5: The Wash Buffer 3 contains different salts in order to purify the nucleic acids (6 x container, Box 4/5). 
Box 1 AltoStar® Purification Kit 1.5: Container Re-Sealing Foil for the AltoStar® Purification Kit 1.5 Lysis Buffer and Wash Buffer 1, 2 and 3 (120 units, Box 5/5).
AltoStar® Purification Kit 1.5 – Content of Box 2
(6 trays with tubes inside)
Box 2 AltoStar® Purification Kit 1.5: This box contains 6 trays. The Enhancer stabilizes and protects nucleic acids against nucleases in solution. The Magnetic Beads are coated with a thin layer of silica to bind free nucleic acids in solution. The magnetic characteristic allows the separation of beads from liquids in a magnetic field. The Elution Buffer is a low salt buffer to elute the nucleic acids from the magnetic beads for subsequent analysis. 
Box 2 AltoStar® Purification Kit 1.5: One tray comprises 4 tubes Magnetic Beads, 2 tubes Elution Buffer and 4 tubes Enhancer.
AltoStar® Purification Kit 1.5
| Order No. | PK15-46 |
| Sample purifications | 1,152 (500 µl sample volume, low volume) or 576 (1,000 µl sample volume, high volume) |
| Transportation | Room temperature |
| Regulatory status | CE-IVD |
AltoStar® Purification Kit 1.5
| Veröffentlichungsdatum: | 04/2022 |
| Regulatorischer Status: | CE-IVD |
| Release date: | 04/2022 |
| Regulatory status: | CE-IVD |
| Date de sortie: | 04/2022 |
| Statut réglementaire: | CE-IVD |
| Fecha de lanzamiento: | 04/2022 |
| Situación reglamentaria: | CE-IVD |
| Data de lançamento: | 04/2022 |
| Estatuto regulamentar: | CE-IVD |
| Data di rilascio: | 04/2022 |
| Stato normativo: | CE-IVD |
| Ngày ban hành: | 04/2022 |
| Tình trạng pháp lý: | CE-IVD |
| Data wydania: | 04/2022 |
| Status prawny: | 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 figure).
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.
2. In the following washing steps, different wash buffers are used to remove proteins and other impurities.
3. Finally, the nucleic acids are released from the magnetic beads with an elution buffer and transferred to the eluate plate.
AltoStar® Purification Kit 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdf| 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| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 24.05.2022 |
| Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |