AltoStar® HHV-6 PCR Kit 1.5

 

IVD 2022 (AS0311543)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® HHV-6 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, differentiation and quantification of human herpesvirus 6A (HHV-6A)
    and human herpesvirus 6B (HHV-6B) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma (HHV-6A)
249 IU/ml
LoD plasma (HHV-6B) 134 IU/ml
LoD whole blood (HHV-6A)

1,112 IU/ml

LoD whole blood (HHV-6B)

653 IU/ml

 

Sample types

The following sample types are validated for use with the AltoStar® HHV-6 PCR Kit 1.5:

 

Human EDTA plasma

Human citrate plasma

Human EDTA whole blood

Human citrate whole blood

Other workflows

The AltoStar® HHV-6 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® HHV-6 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® HHV-6 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® HHV-6 PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection, differentiation and quantification of human herpesvirus 6A (HHV-6A) and human herpesvirus 6B (HHV-6B) specific DNA in human plasma and whole blood. It is intended to be used as an aid for diagnosis of HHV-6 infection and for monitoring of the HHV-6A and HHV-6B load in individuals with HHV-6 infection.

AltoStar® HHV-6 PCR Kit 1.5

Order No.AS0311543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® HHV-6 PCR Kit 1.5

Gebrauchsanweisung AltoStar® HHV-6 PCR Kit 1.5

pdf
File size: 2.72 MB
Veröffentlichungsdatum: 03/2022
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® HHV-6 PCR Kit 1.5

pdf
File size: 2.51 MB
Release date: 03/2022
Regulatory status: CE-IVD

Mode d'emploi AltoStar® HHV-6 PCR Kit 1.5

pdf
File size: 2.77 MB
Date de sortie: 03/2022
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® HHV-6 PCR Kit 1.5

pdf
File size: 2.75 MB
Fecha de lanzamiento: 03/2022
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® HHV-6 PCR Kit 1.5

pdf
File size: 2.74 MB
Data de lançamento: 03/2022
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® HHV-6 PCR Kit 1.5

pdf
File size: 2.71 MB
Data di rilascio: 03/2022
Stato normativo: CE-IVD

AltoStar® HHV-6 PCR Kit 1.5

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

pdf
File size: 534.69 KB
Veröffentlichungsdatum/Release date/Date de sortie: 17.11.2021
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)

pdf
File size: 539.65 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 17.11.2021
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD