The RealStar® MERS-CoV RT-PCR Kit U.S. is a real-time reverse transcriptase polymerase chain reaction (rRT-PCR) test for the in vitro qualitative detection of RNA from MERS-CoV in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors. The RealStar® MERS-CoV RT-PCR Kit U.S. consists of two independent assays, one targeting a region upstream of the E gene (upE) and the other targeting open reading frame 1a (orf1a) of the MERS-CoV genome. Both assays include a heterologous amplification system (Internal Control) to identify possible RT-PCR inhibition and to confirm the integrity of the reagents of the kit.
- 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.