Serological methods and diagnostic tests for syphilis antibodies

A method of manufacturing a non-treponemal diagnostic test for syphilis infection, which comprises:

• initially dissolving cholesterol in an organic solvent and further diluting the dissolved cholesterol in an ethanol solution comprising cardiolipin and lecithin to form an antigen solution;
• permitting a volume of the antigen solution to evaporate in place within a container and at least partially coat the container with an antigen coating;
• rinsing the at least partially coated container with buffered saline;
• stabilizing the antigen coating into a syphilis antigen complex by overcoating the antigen coating with an overcoat solution comprising an inert protein;
• decanting the overcoat solution, drying the container, and sealing the container in a vapor-proof pouch;
• providing an enzyme-labeled conjugate component of a syphilis infection test that is formulated to be compatible with a lipid nature of the cholesterol, the cardiolipin, and the lecithin;
• providing a sample diluent that is formulated to be compatible with the lipid nature of the cholesterol, the cardiolipin, and the lecithin;
• providing a wash fluid that is formulated to be compatible with the lipid nature of the cholesterol, the cardiolipin, and the lecithin;
• and
• providing an enzyme substrate that is formulated to be compatible with the lipid nature of the cholesterol, the cardiolipin, and the lecithin.

A non-treponemal diagnostic test for syphilis infection, comprising:

• a container having an interior that is at least partially coated first with a mixture of cholesterol dissolved in an organic solvent and further diluted in an ethanol solution comprising cardiolipin and lecithin to form an interior antigen coating that is then overcoated with an inert protein dissolved in buffered saline;
• a vapor-proof pouch sealing the container therein after the overcoating is dry;
• an enzyme-labeled conjugate component of a syphilis infection test formulated to be compatible with a lipid nature of the cholesterol, the cardiolipin, and the lecithin;
• a sample diluent formulated to be compatible with the lipid nature of the cholesterol, the cardiolipin, and the lecithin;
• a wash fluid formulated to be compatible with the lipid nature of the cholesterol, the cardiolipin, and the lecithin;
• and
• an enzyme substrate formulated to be compatible with the lipid nature of the cholesterol, the cardiolipin, and the lecithin.