AltoStar® alpha Herpesvirus PCR Kit 1.5

 

IVD 2022 (AS0081543)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® alpha Herpesvirus 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 licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Key features

  • Detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2)
    and varicella-zoster virus (VZV) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in copies/ml

Limit of detection (LoD)

LoD HSV-1
26 copies/ml
LoD HSV-2 37 copies/ml
LoD VZV
91 copies/ml

 

Sample types

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

 

Human cutaneous swab specimens in universal transport medium

Human mucocutaneous swab specimens in universal transport medium

Other workflows

The AltoStar® alpha Herpesvirus 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® alpha Herpesvirus PCR Kit 1.5  are:

 

CFX96™ Deep Well Dx System (Bio-Rad)

CFX96™ Dx System (Bio-Rad)

ABI Prism® 7500 SDS (Applied Biosystems)

QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)

Rotor-Gene® Q5/6 plex Platform (QIAGEN)

 

The AltoStar® alpha Herpesvirus 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® alpha Herpesvirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA in human cutaneous and mucocutaneous swab specimens. It is intended to be used as an aid for diagnosis of HSV-1, HSV-2 and VZV infection.

AltoStar® alpha Herpesvirus PCR Kit 1.5

Order No.AS0081543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® alpha Herpesvirus PCR Kit 1.5

Gebrauchsanweisung AltoStar® alpha Herpesvirus PCR Kit 1.5

pdf
File size: 2.50 MB
Veröffentlichungsdatum: 10/2021
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® alpha Herpesvirus PCR Kit 1.5

pdf
File size: 2.32 MB
Release date: 10/2021
Regulatory status: CE-IVD

Mode d'emploi AltoStar® alpha Herpesvirus PCR Kit 1.5

pdf
File size: 2.54 MB
Date de sortie: 10/2021
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® alpha Herpesvirus PCR Kit 1.5

pdf
File size: 2.53 MB
Fecha de lanzamiento: 10/2021
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® alpha Herpesvirus PCR Kit 1.5

pdf
File size: 2.53 MB
Data de lançamento: 10/2021
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® alpha Herpesvirus PCR Kit 1.5

pdf
File size: 2.48 MB
Data di rilascio: 10/2021
Stato normativoce: CE-IVD

AltoStar® alpha Herpesvirus PCR Kit 1.5

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

pdf
File size: 531.94 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: 539.16 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD