Ultra-sensitive Diagnostic Detects fg/mL-pg/mL Pathogen/Disease Protein by Visual Color Change

This technology is an ultra-sensitive colorimetric assay, based on an enzyme-catalyzed gold nanoparticle growth process, for detection of disease-associated proteins (biomarkers) and disease diagnosis. Current detection methods, such as ELISA immunoassays, measure concentrations above 0.1 ng/mL in a sample. PCR, although more sensitive than ELISA, requires expensive and specialized equipment and reagents, skilled labor, and complex analysis techniques. This assay detects fg/mL to pg/mL concentrations, allowing detection and diagnosis in the earliest stage of disease or infection. A simple to read colorless-to-red change of gold nanoparticle is read with the naked eye, without the need for advanced instruments. This assay can be performed in a standard ELISA plate. Prototype, proof of concept tests using this platform have been designed for enterovirus 71 (EV71) and prostate specific antigen (PSA). The limit of detection (LOD) for a PSA prototype exceeded the commercial ELISA by more than four orders of magnitude. This assay may be particularly well suited for field use/point-of-care detection of infections and early stage disease.

Potential Commercial Applications: Competitive Advantages:
  • Infectious pathogen and disease diagnostics.
  • Orders of magnitude more sensitive than most ELISA (detects fg/mL to pg/mL)
  • Plain sight color-based confirmation does not require complex equipment
  • Field use/point-of-care detection

Development Stage:
  • Early-stage
  • In vitro data available
  • Prototype


Xiaoyuan Chen (NIBIB)  ➽ more inventions...

Dingbin Liu (NIBIB)  ➽ more inventions...

Intellectual Property:
US Pat: 9,903,868 issued 2018-02-27
US Application No. 62/052,866 filed on 2014-09-19
US Application No. 14/714,721 filed on 2015-05-18


Liu D, et al.

PMID 24896231

Collaboration Opportunity:

The National Institute of Biomedical Imaging and Bioengineering is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Cecilia Pazman, Ph.D. at pazmance@mail.nih.gov.

Licensing Contact:
Michael Shmilovich, J.D.
Email: shmilovm@mail.nih.gov
Phone: 301-435-5019

OTT Reference No: E-167-2014-0
Updated: Sep 17, 2015