Technology ID

A Device for Simultaneous and Rapid Diagnosis and Detection of Recent and Long Term HIV-1 Infection

Lead Inventor
Granade, Timothy (CDC)
Pau, Chou-Pong (CDC)
McDougal, Steve (CDC)
Research Materials
Occupational Safety and Health
Non-Medical Devices
Medical Devices
Consumer Products
Therapeutic Areas
Infectious Disease
Development Stages
Development Status
  • Early-stage
  • Prototype
Research Products
Lead IC
CDC scientists have developed a device for simultaneous rapid diagnosis of HIV infection and for identification of recent HIV-1 infection. The device utilizes immunochromatographic or flow-through principles to detect HIV antibodies within clinical samples. This device may be used for diagnosis of HIV infection, as well as to distinguish between recent infection (6 months) and long-term infection (>1 year). This latter application has added significance for surveillance, counseling, partner notification and other related prevention concerns, including the estimation of HIV incidence in cross-sectional populations. The device, if formatted as a self-contained kit, would utilize a single platform containing all required reagents, making it simple and easy for use by minimally trained technicians. The entire testing process, including the determination of incident infections, has been designed to minimize assay processing time. This device has potential as an important tool for regional incidence measurements, which can aid targeting of prevention activities and allocation of resources by HIV/AIDS prevention programs, as well as serve as an indicator of the effectiveness of intervention strategies.
Commercial Applications
  • Routine HIV screening and diagnostics
  • Establishment of a specific "window-of-infection" timeframe
  • HIV/AIDS surveillance programs and evaluation of prevention program effectiveness
  • Identification of high-risk cohorts for vaccine development, microbicide research and targeting resources
  • HIV/AIDS research tool
  • Screening tool for emergency blood donation
Competitive Advantages
  • Simple, single platform testing
  • Greater cost efficiency than current immunoassays in terms of resource input and labor investment
  • Exceptionally rapid assay processing
  • Permits early-as-possible diagnosis, counseling, partner notification and early treatment
  • Assay can be developed for on-site testing, at-home use or resource-limited environments using finger prick blood samples
Licensing Contact:
Mitzelfelt, Jeremiah