AltoStar® VZV PCR Kit 1.5

 

AS0071543

 

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® VZV 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.

Products not FDA cleared or approved. Kits not available in all countries.

Key features

  • Detection and quantification of varicella-zoster virus (VZV) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in copies/ml

Limit of detection (LoD)

LoD plasma 73 copies/ml

 

Sample types

The following sample types are validated for use with the AltoStar® VZV PCR Kit 1.5:

 

Human EDTA plasma

Human citrate plasma

Other workflows

The AltoStar® VZV 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® VZV 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® VZV 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® VZV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of varicella-zoster virus (VZV) specific DNA in human plasma. It is intended to be used as an aid for diagnosis of VZV infection and for monitoring of the VZV load in individuals with VZV infection.

AltoStar® VZV PCR Kit 1.5

Order No.AS0071543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® VZV PCR Kit 1.5

Gebrauchsanweisung AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.30 MB
Veröffentlichungsdatum: 09/2022
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.20 MB
Release date: 09/2022
Regulatory status: CE-IVD

Mode d'emploi AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.35 MB
Date de sortie: 09/2022
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.31 MB
Fecha de lanzamiento: 09/2022
Situación reglamentaria: CE-IVD

Instruções de utilização AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.32 MB
Data de lançamento: 09/2022
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.31 MB
Data di rilascio: 09/2022
Stato normativo: CE-IVD

🇳🇴 Bruksanvisning AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.22 MB
Utgivelsesdato: 09/2022
Regulatorisk status: CE-IVD

🇵🇱 Instrukcja użytkowania AltoStar® VZV PCR Kit 1.5

pdf
File size: 4.32 MB
Data wydania: 09/2022
Status prawny: CE-IVD

AltoStar® VZV PCR Kit 1.5

Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)

pdf
File size: 518.96 KB
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
File size: 534.12 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD