Technology Bundle ID: TAB-3268

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

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Primary Inventors: 
William Nix (CDC)
Co-Inventors: 
Mark Oberste (CDC)
Development Stage: 
Pre-Clinical (in vitro)
Institute or Center: 
CDC

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.

Applications:
  • Rapid, simple and specific detection of new human EV-D68 strains
  • Assay for research or clinical settings to diagnose respiratory infections directly attributable to EV-D68 versus other causative agents – for adults, children or neonates
  • Government and regional Enterovirus surveillance programs
  • Quality control/quality assurance testing for Enterovirus isolates
Advantages:
  • Detection of currently circulating, newly evolved human EV- D68 strains
  • Simple and rapid as compared to previous methods, making the diagnosis easier
  • High sensitivity and specificity
  • Validated and easily implementable as a kit or array for high-throughput sample screening
  • Faster screening than culturing and serological identification methods
  • This assay was approved under an Emergency Use Authorization (EUA) by the FDA in May, 2015

Patents

US Application 62/171,657
Filed on 2015-06-05
US Pat 9,938,588

Issued 2018-04-10

Publications

Aliabadi N, et al.
PMID 27434186
Brown BA, et al.
PMID 25414503
Medical Devices - Emergency Use Authorizations
fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm
Messacar K, et al.
PMID 25638662
Midgley CM, et al.
PMID 25211545
Midgley CM, et al.
PMID 26482320
Rhoden E, et al.
PMID 26149998

Updated

Jun 5, 2018

Data Source: 
tts