AltoStar® BKV PCR Kit 1.5
AS0031543
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® BKV PCR 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.
AltoStar® BKV PCR Kit 1.5 
AltoStar® BKV PCR Kit 1.5
Products not FDA cleared or approved. Kits not available in all countries.
Key features
- Detection and quantification of BK virus (BKV) specific DNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD plasma | 66 IU/ml |
| LoD whole blood | 105 IU/ml |
| LoD urine |
21 IU/ml |
Sample types
The following sample types are validated for use with the AltoStar® BKV PCR Kit 1.5:
Human EDTA plasma
Human citrate plasma
Human EDTA whole blood
Human citrate whole blood
Human urine
Other workflows
The AltoStar® BKV PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar® BKV PCR Kit 1.5 are:
CFX96™ Deep Well Dx System (Bio-Rad)
CFX96™ Dx System (Bio-Rad)
ABI Prism® 7500 SDS (Applied Biosystems)
LightCycler® 480 Instrument II (Roche)
QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)
Rotor-Gene® Q5/6 plex Platform (QIAGEN)
The AltoStar® BKV PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.
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 BK virus (BKV) specific DNA in human plasma, whole blood and urine. It is intended to be used as an aid for diagnosis of BKV infection and for monitoring of the BKV load in individuals with BKV infection.
AltoStar® BKV PCR Kit 1.5
| Order No. | AS0031543 |
| Rxns | 96 |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
AltoStar® BKV PCR 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 |
| Data wydania: | 04/2022 |
| Status prawny: | CE-IVD |
| Ngày ban hành: | 04/2022 |
| Tình trạng pháp lý: | CE-IVD |
AltoStar® BKV PCR Kit 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, PT, IT)
pdf| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
| Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |