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.