Diagnostic Assay with Modified Cardiolipin for Detecting Active Syphilis Infections

Syphilis is a sexually transmitted infection that remains a global health threat. The World Health Organization estimates that more than 12 million new cases are reported in adults annually worldwide. Syphilis rates are rising domestically as well. The rapid plasma reagin (RPR) test (including automated version) and the Venereal Disease Research Laboratory (VDRL) test are commercially available and used to detect/screen active infection.

CDC researchers have also developed a rapid serological test that detects active syphilis infections. The test is an immunoassay that uses modified cardiolipin as an antigen to detect anti-cardiolipin antibodies produced in response to lipoidal components released from host cells or Treponema pallidum cells damaged during the course of infection, offering a method of detecting active syphilis infections. This invention also comprises a method for preparing oxidized cardiolipin so that it is capable of linking to a protein for attachment to a solid support (such as a microporous membrane (i.e., nitrocellulose) or multi-well plate).

Potential Commercial Applications: Competitive Advantages:
  • Clinical diagnosis of active syphilis infections
  • Monitoring of infection status in response to standard syphilis treatment
  • Can be used to detect nontreponemal antibodies only or used in assays which co-detect nontreponemal and treponemal antibodies
  • Monitoring and public health surveillance
  • Can differentiate between prior exposure and active infection of syphilis
  • Can be used in lateral flow, flow-through, or enzyme-linked immunosorbent assay (ELISA) testing formats
  • Can be used in a point-of-care assay allowing for convenience, rapid results, low cost, and field use

Related Invention(s):


Arnold Castro (CDC)  ➽ more inventions...

Huiying Wang

Intellectual Property:
US Pat: 7,888,043 issued 2011-02-15
PCT Pat: 8,906,603 issued 2014-12-09
US Application No. 12/094,144 filed on 2008-05-16
US Application No. 13/027,224 filed on 2011-02-14
International patents issued in Brazil, China, Japan, and Europe

Marks M. et al. PMID 27217216
Kalou MB et al. PMID 28879115

Collaboration Opportunity:

The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize- Diagnostic Assay with Modified Cardiolipin for Detecting Active Syphilis Infections. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov or 1-404-639-1330.

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

OTT Reference No: E-310-2013-0
Updated: Sep 27, 2018