AltoStar® EBV PCR Kit 1.5
AS0131543
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® EBV 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® EBV PCR Kit 1.5 
AltoStar® EBV PCR Kit 1.5
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
Key features
- Detection and quantification of Epstein-Barr virus (EBV) specific DNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD plasma | 195 IU/ml |
| LoD whole blood |
320 IU/ml |
Sample types
The following sample types are validated for use with the AltoStar® EBV PCR Kit 1.5:
Human EDTA plasma
Human citrate plasma
Human EDTA whole blood
Human citrate whole blood
Other workflows
The AltoStar® EBV 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® EBV 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® EBV 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® EBV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of Epstein-Barr virus specific DNA in human plasma and whole blood. It is intended to be used as an aid for diagnosis of EBV infection and for monitoring of the EBV load in individuals with EBV infection.
AltoStar® EBV PCR Kit 1.5
| Order No. | AS0131543 |
| Rxns | 96 |
| Transportation | Dry ice |
| Regulatory status | CE-IVD |
AltoStar® EBV PCR Kit 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 |
| Utgivelsesdato: | 10/2021 |
| Regulatorisk status: | CE-IVD |
| Data wydania: | 10/2021 |
| Status prawny: | CE-IVD |
| Data wydania: | 10/2021 |
| Status prawny: | CE-IVD |
AltoStar® EBV 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, IT, PT)
pdf| Fecha de lanzamiento/Data di rilascio/Data de lançamento: | 18.05.2022 |
| Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |