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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.