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).