Real-time RT-PCR Assay for Rapid, Highly Sensitive and Specific Detection of Human Enterovirus D68 (EV-D68)

Human Enterovirus D68 (EV-D68) is a non-polio enterovirus that can cause mild to severe respiratory illness, especially in infants and children with asthma. Since its identification, every year EV-D68 has been detected sporadically throughout the world. The US experienced a nationwide outbreak of EV-D68 associated with a particularly severe respiratory illness from mid-August to early November 2014, with 1,153 confirmed cases in 49 states and the District of Columbia. Although various established detection methods are available for EV-D68, enteroviruses evolve rapidly. New methods are needed for specific testing to determine which types of enteroviruses are circulating.

CDC investigators have developed a real-time RT-PCR (reverse transcriptase – polymerase chain reaction) Taqman assay using primers and probes specific for EV-D68 viral protein 1 nucleic acid. This assay provides a more specific identification of EV-D68 strains allowing better diagnosis. The assay is simple, validated, and allows rapid testing and detection of EV-D68 in respiratory samples. This assay can be used in a kit or an array format for high-throughput (large scale) screening of samples, which is useful for public health facilities and surveillance programs. This assay was approved under an Emergency Use Authorization (EUA) by the FDA (US Food and Drug Administration) in May, 2015.