AltoStar® MERS-CoV RT-PCR Kit 1.5

 

IVD 2022 (AS0391543)

 

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

Key features

  • Detection of Middle East respiratory syndrome coronavirus (MERS-CoV) specific RNA
  • Consists of two independent assays, one targeting a region upstream of the E gene (upE) as well as a region of the N gene and the other targeting open reading frame 1a (orf1a) of the MERS-CoV genome.
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in copies/ml

Limit of detection (LoD)

LoD upE + N gene 72.9 copies/ml
LoD orf1a 332 copies/ml

 

 

 

Sample type

The following sample type is validated for use with the AltoStar® MERS-CoV RT-PCR Kit 1.5:

 

Human nasopharyngeal swabs

Other workflows

The AltoStar® MERS-CoV 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® MERS-CoV 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® MERS-CoV 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® MERS-CoV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of Middle East respiratory syndrome coronavirus (MERS-CoV) specific RNA in human nasopharyngeal swabs. It is intended to be used as an aid for diagnosis of MERS-CoV infection.

AltoStar® MERS-CoV RT-PCR Kit 1.5

Order No.AS0391543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® MERS-CoV RT-PCR Kit 1.5

Gebrauchsanweisung AltoStar® MERS-CoV RT-PCR Kit 1.5

pdf
File size: 2.99 MB
Veröffentlichungsdatum: 04/2022

Instructions for use AltoStar® MERS-CoV RT-PCR Kit 1.5

pdf
File size: 3.16 MB
Release date: 04/2022

Mode d'emploi AltoStar® MERS-CoV RT-PCR Kit 1.5

pdf
File size: 3.01 MB
Date de sortie: 04/2022

Instrucciones de uso AltoStar® MERS-CoV RT-PCR Kit 1.5

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File size: 3.00 MB
Fecha de lanzamiento: 04/2022

Instruções de utilização AltoStar® MERS-CoV RT-PCR Kit 1.5

pdf
File size: 3.01 MB
Data de lançamento: 04/2022

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

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File size: 2.98 MB
Data di rilascio: 04/2022

AltoStar® MERS-CoV RT-PCR Kit 1.5

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

pdf
File size: 527.69 KB
Veröffentlichungsdatum/Release date/Date de sortie: 18.05.2022

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

pdf
File size: 538.05 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 18.05.2022