AltoStar® Internal Control 1.5
IC15-46
In the course of the 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.
AltoStar® Internal Control 1.5 
AltoStar® Internal Control 1.5
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 |
| Rxns | 1,152 (500 µl sample volume, low volume) or 576 (1,000 µl sample volume, high volume) |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
AltoStar® Internal Control 1.5
| Veröffentlichungsdatum: | 10/2021 |
| Regulatorischer Status: | CE-IVD |
| Release date: | 10/2021 |
| Regulatory status: | CE-IVD |
| Date de sortie: | 10/2021 |
| Statut réglementaire: | CE-IVD |
| Fecha de lanzamiento: | 10/2021 |
| Situación reglamentaria: | CE-IVD |
| Data de lançamento: | 10/2021 |
| Estatuto regulamentar: | CE-IVD |
| Data di rilascio: | 10/2021 |
| Stato normativo: | CE-IVD |
| Ngày ban hành: | 10/2021 |
| Tình trạng pháp lý: | CE-IVD |
| Data wydania: | 10/2021 |
| 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 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).
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® Internal Control 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdf| 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)
pdf| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
| Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |