Lateral Flow Immunoassay
Diafactory® Tinea Unguium is an immunochromatography kit intended to detect Trichophyton-derived antigens in nails using anti-Trichophyton mouse monoclonal antibody that has been immobilized on a nitrocellulose membrane.
The test strip used in this kit is composed of a sample pad, a reagent strip, a judgment strip and an absorbent pad.
The reagent strip contains gold colloid-labeled anti-Trichophyton mouse monoclonal antibody in the dry state, and the judgment strip contains anti-Trichophyton mouse monoclonal antibody in the dry state affixed on the test line zone and the dye in the dry state affixed on the control line zone.
This dye is a colorless dye at a pH of 3 that turns pink at a pH of approximately 4 or higher, and allows the user to confirm that a sample has correctly passed through the test line zone.
From sample to result
A sample that has infiltrated the sample pad (hereinafter called, "the extracted sample") moves to the reagent strip, on which a Trichophyton-derived antigen in the extracted sample binds to a gold colloid-labeled anti-Trichophyton mouse monoclonal antibody to form an immune complex.
While proceeding through the judgment strip, the immune complex is captured by the anti-Trichophyton mouse monoclonal antibody affixed on the test line zone, resulting in the appearance of a purple line of gold colloid (in case it is positive).
If the sample does not contain Trichophyton-derived antigen, no immune complexes are formed and the sample containing unbound gold colloid-labeled anti-Trichophyton mouse monoclonal antibody passes over the test line zone without producing a visible band on the test line zone.
The extracted sample containing unused gold colloid labeled anti-Trichophyton mouse monoclonal antibodies, whether it is Trichophyton-derived antigen positive or negative, passes through the test line zone and reaches the control line zone, where the extracted sample reacts with immobilized dye, resulting in the appearance of a pink band.