Novel Enzyme-Based Immunoassay for Simultaneous Detection of Hepatitis C Virus Antigen and Antibody in Human Serum or Plasma


CDC scientists have developed a novel enzyme immunoassay for the simultaneous detection of hepatitis C virus (HCV) core antigen and circulating HCV antibodies. Serological testing procedures for HCV circulating antibodies are well established. There is, however, a window of time between HCV infection and seroconversion that generates an opportunity for false negative results. This period varies from two months in immunocompetent subjects to six to twelve months in immunodeficient patients. Combination testing, utilizing both serological testing and PCR-based techniques, can be used to overcome this limitation. PCR-based techniques, however, are costly and time-consuming and present considerable challenges to clinical laboratories, due to equipment requirements and sensitivity to cross-contamination.

This technology overcomes these challenges through simultaneous detection of both HCV core antigen and HCV antibody in an immunoassay format, which both significantly improves the sensitive diagnosis of hepatitis C among blood donors at any stage of infection and is also simpler to perform than combination testing utilizing PCR-based techniques.

Potential Commercial Applications: Competitive Advantages:
  • Monitoring and early, accurate diagnosis of hepatitis C virus (HCV) infected individuals
  • Rapid screening tool for blood donations and high-risk individuals
  • Lateral-flow assays, HCV detection kits
 
  • Efficiently overcomes the window of potential false-negative diagnosis between time of inital hepatitis C infection and patient seroconversion by implementation of an accurate, sensitive immunoassay
  • Assay significantly improves diagnosis beyond stand-alone HCV core antigen or antibody measures
  • Detects the presence of HCV both prior to and following seroconversion without reliance on PCR-based techniques


Development Stage:
In vitro data available

Inventors:

Yury Khudyakov (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 14/890,299
US Application No. 61/821,953
PCT Application No. PCT/US2014/037648

Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-190-2013/0
Updated: Jul 9, 2014