AltoStar® BKV PCR Kit 1.5
The AltoStar® PCR Kits 1.5 are developed for the simultaneous testing of pathogens by harmonized cycling conditions and enabling the identification of clinical pathogen using the AltoStar® Molecular Diagnostic Workflow. The AltoStar® BKV PCR Kit 1.5 is part of the pathogen panel for testing immunocompromised patients.
The AltoStar® BKV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of BKV specific DNA in human EDTA plasma and human Citrate plasma. 
The AltoStar® BKV PCR Kit 1.5 consists of: Two Master reagents (Master A and Master B), Four Quantification Standards (QS1 - QS4), PCR grade water.
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
Key Features
- Detection and Quantification of BK Virus (BKV) specific DNA
- Ready-to-use Kit including Quantification Standards
- Quantification Standards calibrated against the 1 st WHO International Standard for BK Virus for Nucleic Acid Amplification Techniques (NAT) (NIBSC code 14/212)
- Analytical sensitivity reported in IU/ml
- Mixed batches possible: all sample types in parallel
- Simultaneous processing: up to 8 assays in the same run
- CE-IVD marked in vitro Diagnostic Test
Intended Use
The AltoStar® BKV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of BKV specific DNA in human plasma and whole blood. The AltoStar® BKV PCR Kit 1.5 is configured for use with the CFX96™ Deep Well Real-Time PCR Detection System (Bio-Rad) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5.
AltoStar® BKV PCR Kit 1.5
| Order No. | AS0031513 |
| Rxns | 96 |
| Sample Types | Human EDTA plasma Human citrate plasma Human EDTA whole blood Human citrate whole blood |
| Transportation | Dry ice |
| For use with | AltoStar® Automation System AM16 / AltoStar® Connect Software AltoStar® Purification Kit 1.5 AltoStar® Internal Control 1.5 CFX96™ Deep Well Real-Time PCR Detection System-IVD |
The results generated with the AltoStar® BKV PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® BKV PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.
AltoStar® BKV PCR Kit 1.5
Instruções de Utilização AltoStar® BKV PCR Kit 1.5
pdf| Data de lançamento: | 06/2019 |
| Filesize: | 3.87 MB |
AltoStar® BKV PCR Kit 1.5
Konformitätserklärung/Declaration of Conformity/Déclaration de conformité - DE, EN, FR
pdf| Veröffentlichungsdatum/Release date/ Date de sortie: | 21.02.2020 |
| Filesize: | 545.93 KB |
Declaración de conformidad/Declaração de conformidade/Dichiarazione di Conformità - ES, PT, IT
pdf| Fecha de lanzamiento/Data de lançamento/Data di uscita: | 21.02.2020 |
| Filesize: | 556.80 KB |