AltoStar® HEV RT-PCR Kit 1.5

 

IVD 2022 (AS0271543)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® HEV RT-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 quantification of hepatitis E virus (HEV) specific RNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma 3.41 IU/ml

 

Sample types

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

 

Human EDTA plasma

Human citrate plasma

Other workflows

The AltoStar® HEV RT-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® HEV RT-PCR Kit 1.5 are:

 

CFX96 Deep Well Dx System (Bio-Rad)

ABI Prism® 7500 SDS (Applied Biosystems)

LightCycler® 480 Instrument II (Roche)

 

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

AltoStar® HEV RT-PCR Kit 1.5

Order No.AS0271543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® HEV RT-PCR Kit 1.5

Gebrauchsanweisung AltoStar® HEV RT-PCR Kit 1.5

pdf
File size: 3.26 MB
Veröffentlichungsdatum: 10/2021
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® HEV RT-PCR Kit 1.5

pdf
File size: 3.06 MB
Release date: 10/2021
Regulatory status: CE-IVD

Mode d'emploi AltoStar® HEV RT-PCR Kit 1.5

pdf
File size: 3.29 MB
Date de sortie: 10/2021
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® HEV RT-PCR Kit 1.5

pdf
File size: 3.26 MB
Fecha de lanzamiento: 10/2021
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® HEV RT-PCR Kit 1.5

pdf
File size: 3.27 MB
Data de lançamento: 10/2021
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® HEV RT-PCR Kit 1.5

pdf
File size: 3.26 MB
Data di rilascio: 10/2021
Stato normativo: CE-IVD

AltoStar® HEV RT-PCR Kit 1.5

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

pdf
File size: 533.71 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: 537.83 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD