Agglutination assay

A test kit for quantitative determination of an analyte in a sample by inhibition of agglutination, comprising:

• at least two analyte standards having different analyte concentrations;
• analyte sensitized particles;
• a binder for the analyte;
• buffered diluent for making serial dilutions of an analyte sample;
• and
• a test card, said test card having a surface including a sample portion and a standard portion, said sample portion being comprised of at least one series of separated marked serial dilution areas for receiving a series of serial dilutions of an analyte sample each having an indicia of the dilution, said standard portion including at least two separated marked standard areas for receiving analyte standards of different analyte concentration, each having an indicia of the analyte concentration, whereby a quantitative determination of analyte in a sample can be determined directly on the test card by serial dilution of sample on the test substrate, adding the binder for the analyte and analyte sensitized particles to the serial diluted analyte samples and analyte standards and determining the lowest standard concentration and the highest dilution at which agglutination is inhibited.

An assay for quantitative determination of an analyte comprising:

• serial diluting an analyte sample directly on at least one series of separated marked serial dilution areas on a surface of a test card, each of the dilution areas having an indicia of the dilution;
• providing at least two analyte standards, each having a different analyte concentration on separated marked standard areas on a surface of the test card, each of the standard areas having an indicia of the analyte concentration;
• adding binder for the analyte and particles sensitized with analyte to each of the analyte standards and each of the analyte sample serial dilutions;
• and determining the quantity of analyte in the sample from the lowest standard concentration and the highest reciprocal sample dilution which shows no visible agglutination.