RealStar® MERS-CoV RT-PCR Kit U.S.*



The RealStar® MERS-CoV RT-PCR Kit U.S.* RT-PCR Kit U.S. is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from Middle East respiratory syndrome coronavirus (MERS-CoV):

 

  • in lower respiratory samples (tracheal aspirate / tracheal secretions) from patients with signs and symptoms of Middle East respiratory syndrome coronavirus infection in conjunction with epidemiological risk factors.

  • in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV cases based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated).



The RealStar® MERS-CoV RT-PCR Kit U.S.* is ready-to-use and compatible with various real-time PCR platforms.

 

  • This test has not been FDA-cleared or approved;
  • This test has been authorized by FDA under an EUA for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories;
  • This test has been authorized only for the detection of MERS-CoV; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of MERS-CoV under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

Any adverse events should be sent to the following Email adress: support@altona-diagnostics.com

 

Prod. No Product For use with
391022 RealStar® MERS-CoV RT-PCR
Kit U.S.*

Download Manual
Version 07/2016
ABI Prism® 7500 SDS and 7500 Fast SDS, CFX96™ system/DX real-time system, CFX96™ Touch Deep Well Real-Time PCR Detection System, LightCycler® 480 Instrument II, Rotor-Gene® 6000, Rotor-Gene® Q 5/6 plex Platform, VERSANT® kPCR Molecular System AD 
     

Please find here further important documents:

 

Letter of Authorization (Date of EUA issuance 2016-02-12) (PDF) 

Fact Sheet for Asymptomatic Individuals (PDF)

Fact Sheet for Health Care Providers (PDF)

Fact Sheet for Patients (PDF)

 


*only available in USA

altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg
Germany

phone +49 40 548 06 76 - 0
fax +49 40 548 06 76 - 10
e-mail info@altona-diagnostics.com