AltoStar® HAV RT-PCR Kit 1.5

 

IVD 2022 (AS0241543)

 

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Key features

  • Qualitative detection of hepatitis A virus (HAV) specific RNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma 6.31 IU/ml

 

Sample types

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

 

Human EDTA plasma

Human citrate plasma

Other workflows

The AltoStar® HAV 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® HAV RT-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® HAV 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® HAV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of hepatitis A virus (HAV) specific RNA in human plasma. It is intended to be used as an aid for diagnosis of HAV infection.

AltoStar® HAV RT-PCR Kit 1.5

Order No.AS0241543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® HAV RT-PCR Kit 1.5

Gebrauchsanweisung AltoStar® HAV RT-PCR Kit 1.5

pdf
File size: 2.62 MB
Veröffentlichungsdatum: 04/2022
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® HAV RT-PCR Kit 1.5

pdf
File size: 2.57 MB
Release date: 04/2022
Regulatory status: CE-IVD

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

pdf
File size: 2.66 MB
Date de sortie: 04/2022
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® HAV RT-PCR Kit 1.5

pdf
File size: 2.65 MB
Fecha de lanzamiento: 04/2022
Situación reglamentaria: CE-IVD

Instruções de utilização AltoStar® HAV RT-PCR Kit 1.5

pdf
File size: 2.65 MB
Data de lançamento: 04/2022
Estatuto regulamentar: CE-IVD

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

pdf
File size: 2.64 MB
Data di rilascio: 04/2022
Stato normativo: CE-IVD

AltoStar® HAV RT-PCR Kit 1.5

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

pdf
File size: 532.53 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: 541.60 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD