AltoStar®MERS-CoV RT-PCR Kit 1.5

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.

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.