The new integrated device the researchers are developing may allow cost effective, point-of-care diagnosis of these agents within one to two hours, according to principal investigator Kelly Henrickson, M.D., professor of pediatrics and microbiology at the Medical College. Dr. Henrickson is also a pediatric infectious disease specialist at Children's Hospital of Wisconsin.
Dr. Henrickson previously developed the Hexaplex diagnostic test, using specialized reagents and genetic data for rapid, accurate simultaneous detection of the seven most common lower respiratory viruses, including several varieties of influenza. This technology is the basis for an array of products for physicians worldwide to rapidly detect the microbes responsible for a variety of illnesses such as aseptic meningitis, chicken pox, chronic cough syndrome, encephalitis, herpes, influenza, pneumonia, SARS, shingles, and West Nile virus.
"Our laboratory has pioneered a flexible, rapid, sensitive and specific method of simultaneously detecting multiple pathogens," says Dr. Henrickson. "We have recently developed two BioTplex assays that detect many (15) category 'A' bioterrorism agents. However, new amplified DNA detection and nucleic acid purification methods beyond those used in the Hexaplex diagnostic test allow for the development of a single 'point-of-care' device that may enhance the speed, flexibility, throughput, and cost effectiveness of multiplex assays."
Infectious agents identified to pose the greatest potential threat (Category "A" agents) include Variola major (smallpox), Bacillus anthracis (anthrax), Yersinia pestis (plague), Clostridium botulinum toxin (botulism), Francisella tularensis (tularaemia), and a group of RNA viruses that cause hemorrhagic fevers (VHFs).
Another agent of grave concern is avian flu. Additional concern exists over bird-to-human spread of avian flu and the potential adaptation for human-to-human spread. Terrorists could take advantage of avian flu's flexibility and engineer more virulent strains, capable of causing worldwide pandemics. Current diagnostic assays are directed to the common human isolates of influenza A, but no assay is available to detect all of the avian varieties of influenza A, according to Dr. Henrickson.
The Medical College of Wisconsin, Children's Hospital, Children's Research Institute, and Nanogen Inc. will participate in carrying out the work of the grant.