Performance and clinical validation of the RealStar® MERS-CoV Kit for detection of Middle East respiratory syndrome coronavirus RNA

Abstract

The kit is a valuable tool for assisting in the rapid diagnosis, patient management and epidemiology of suspected MERS-CoV cases.

Emerging respiratory infections: The infectious disease pathology of SARS, MERS, pandemic influenza, and Legionella

“…Two RT-PCR testing strategies have been granted emergency use authorization by the FDA: both target a region upstream of the envelope gene; while one additionally targets a region of the ORF1a gene, the other targets two regions within the nucleocapsid gene. 41,42 Serology in MERS-CoV infection follows similar kinetics to that of SARS-CoV. The majority of patients develop detectable levels of IgM and IgG antibodies 2-3 weeks following symptom onset.…”

Middle East Respiratory Syndrome

“…Lower respiratory tract specimens have been found to be more sensitive than upper respiratory tract specimens for the detection of MERS-CoV (32). In addition, the development of a rapid diagnostic kit is important for the timely diagnosis of suspected MERS-CoV cases (45). Serological testing for MERS-CoV has been developed to detect antibodies, and it can be used to screen the contacts of infected patients and to retrospectively confirm MERS-CoV infections (46).…”

MERS coronavirus outbreak: Implications for emerging viral infections

“…The bases for WHO and CDC definitions are shown in Table 1. Viral nucleic acid confirmation can be either by positive results for nucleic acid amplification assays (NAAT), for example reverse transcription polymerase chain reaction (RT-PCR) directed against a minimum of 2 specific genomic targets (either upstream of the E protein gene (upE) and ORF1a, ORF1b or N gene), or against a single positive target with sequencing of a second target, preferably the RNA-dependent RNA polymerase (RdRp; nsp12) or N genes (Al Johani and Hajeer, 2016; Centers for Disease Control and Prevention, 2017;Corman et al, 2012aCorman et al, , 2014cWorld Health Organization, n.d., 2018). In the USA, an Emergency Use Authorization (EUA) was issued by the FDA to authorize the use of the WHOapproved RealStar® MERS-CoV RT-PCR Kit, as there is currently no FDA-cleared/approved test available for MERS-CoV testing in the USA (Centers for Disease Control and Prevention, 2017;Corman et al, 2012a;Food and Drug Administration, 2016;Lu et al, 2014a).…”

“…The CDC validated a suggested alternate testing strategy based on screening of one N gene signature sequence (N2) combined with upE testing for enhanced sensitivity, and a second N gene signature (N3) for confirmation of positive tests (Lu et al, 2014a;World Health Organization, 2018). Corman and colleagues ultimately developed the upE and ORF1a real-time PCRs into the RealStar® MERS-CoV RT-PCR Kit, which was clinically validated using samples of a German MERS-CoV case and respiratory samples from other respiratory disease patients (Corman et al, 2014c). The RealStar® MERS-CoV RT-PCR Kit has been WHO approved and granted an FDA Emergency Use Authorization (EUA) in the United States (Food and Drug Administration, 2016;World Health Organization, n.d.).…”