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Home / AltoStar® / AltoStar® MERS-CoV RT-PCR Kit 1.5

AltoStar® MERS-CoV RT-PCR Kit 1.5

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.

Specifications

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 types

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.

 

 

Order No
AS0391543
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD

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

Manuals AltoStar® MERS-CoV RT-PCR Kit 1.5
Associated documents AltoStar® MERS-CoV RT-PCR Kit 1.5
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Manuals AltoStar® MERS-CoV RT-PCR Kit 1.5
Language
AltoStar® MERS-CoV RT-PCR Kit 1.5 - DE
Language: German
Date: 2022-04
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - EN
Language: English
Date: 2022-04
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2022-04
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - FR
Language: French
Date: 2022-04
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2022-04
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2022-04
Panel: Respiratory infections
Regulatory status: CE-IVD
Associated documents AltoStar® MERS-CoV RT-PCR Kit 1.5
Language
Type of document
AltoStar® MERS-CoV RT-PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® MERS-CoV RT-PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD