AltoStar® CMV PCR Kit 1.5

 

IVD 2022 (AS0021543)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® CMV 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 cytomegalovirus (CMV) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma 215 IU/ml
LoD whole blood
305 IU/ml
LoD urine
711 IU/ml

 

Sample types

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

 

Human EDTA plasma

Human citrate plasma

Human EDTA whole blood

Human citrate whole blood

Human urine

Other workflows

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

AltoStar® CMV PCR Kit 1.5

Order No.AS0021543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® CMV PCR Kit 1.5

Gebrauchsanweisung AltoStar® CMV PCR Kit 1.5

pdf
File size: 3.18 MB
Veröffentlichungsdatum: 08/2021
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® CMV PCR Kit 1.5

pdf
File size: 3.19 MB
Release date: 08/2021
Regulatory status: CE-IVD

Mode d'emploi AltoStar® CMV PCR Kit 1.5

pdf
File size: 3.52 MB
Date de sortie: 08/2021
Statut réglementaire: CE-IVD

Instrucciones de uso AltoStar® CMV PCR Kit 1.5

pdf
File size: 3.15 MB
Fecha de lanzamiento: 08/2021
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® CMV PCR Kit 1.5

pdf
File size: 3.15 MB
Data de lançamento: 08/2021
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® CMV PCR Kit 1.5

pdf
File size: 3.14 MB
Data di rilascio: 08/2021
Stato normativo: CE-IVD

AltoStar® CMV RT-PCR Kit 1.5 - Certificates

AltoStar® CMV PCR Kit 1.5 - EG-Zertifikat-QM-System_CMV-HCV-HBV-HIV (DE)

pdf
File size: 746.70 KB
Veröffentlichkeitsdatum: 05.11.2021

AltoStar® CMV PCR Kit 1.5 - Certificate_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (EN)

pdf
File size: 1.24 MB
Release Date: 05.11.2021

AltoStar® CMV PCR Kit 1.5 - Certificat_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (FR)

pdf
File size: 1.44 MB
Date de sortie: 05.11.2021

AltoStar® CMV PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV_HCV-HBV-HIV (ES)

pdf
File size: 1.15 MB
Fecha de lanzamiento: 05.11.2021

AltoStar® CMV PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (PT)

pdf
File size: 1.25 MB
Data de lançamento: 05.11.2021

AltoStar® CMV PCR Kit 1.5 -Certificate_Sistema di qualita_Annex IV 98-79 CE CMV-HCV-HBV-HIV (IT)

pdf
File size: 1.44 MB
Data di uscita: 05.11.2021

AltoStar® CMV PCR Kit 1.5

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

pdf
File size: 536.46 KB
Veröffentlichungsdatum/Release date/ Date de sortie: 04.11.2021
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

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

pdf
File size: 553.19 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 04.11.2021
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD