Enterovirus Molecular Diagnostic Test Kit

CDC researchers have developed a reverse transcription/semi-nested polymerase chain reaction (RT-snPCR) assay for diagnosis of enterovirus infections within clinical specimens. Clinical laboratories currently identify enteroviruses by virus isolation and subsequent virus neutralization tests, or serological assays. In addition to being time consuming, these approaches are labor, cost and material intensive.

The enterovirus molecular diagnostic test is prepared in a kit form, consisting of three reagent preparations (three separate test steps), to which a technician adds enzymes and RNA extracted from a clinical specimen. This format is amenable to commercial manufacturing processes. The assay primers were designed for broad specificity and amplify all recognized enterovirus serotypes. In the course of assay development, PCR products have been successfully amplified and sequenced from cerebrospinal fluid, nasopharyngeal swabs, eye swabs, rectal swabs and stool suspensions, allowing for unambiguous identification of the infecting virus in all cases. This assay will be useful for the diagnosis of numerous common illnesses, such as foot-and-mouth disease, respiratory illness, conjunctivitis, neonatal illness, and myocarditis, among several others.

Potential Commercial Applications: Competitive Advantages:
  • Detection and identification of enterovirus infections, such as foot-and-mouth disease
  • Diagnostic evaluations of respiratory or neonatal illnesses
  • Enterovirus surveillance programs for humans and animals/livestock
  • Ready for commercialization
  • Easily adaptable to kit form
  • Rapid, cost-efficient serotype identification
  • High specificity and precision
  • Assay covers all known human enterovirus serotypes

Development Stage:
In vitro data available


William Nix (CDC)  ➽ more inventions...

Mark Oberste (CDC)  ➽ more inventions...

Intellectual Property:
US Pat: 7,247,457 issued 2007-07-24
US Pat: 7,714,122 issued 2010-05-11
Various international patents issued or pending

Nix WA, et al. PMID 16891480
Nix WA, et al. PMID 18596147

Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719

OTT Reference No: E-257-2013-0
Updated: Feb 6, 2014