Agglutination immunoassay and kit for determination of a...

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G01N 33/546 (2006.01) G01N 33/532 (2006.01) G01N 33/543 (2006.01) G01N 33/569 (2006.01) G01N 33/58 (2006.01) G01N 33/76 (2006.01)

Patent

CA 1308349

AGGLUTINATION IMMUNOASSAY AND KIT FOR DETERMINATION OF A MULTIVALENT IMMUNE SPECIES USING BUFFERED SALT WASH SOLUTION Abstract of the Disclosure A test kit is used in an agglutination immunoassay to determine a multivalent immune species, such as Streptococcus A antigen, in a bio- logical sample. The method includes contacting an aqueous solution of the species with an agglutination indicator reagent having receptor molecules reactiue with the species to form an agglutinate of the reac- tion product of species and receptor. These receptor mnlecules are bound to polymeric particles which contain tracer molecules. The resulting agglutinate is captured on a microporous membrane which has an average pore size which is at least five times greater than the average diameter of the polymeric particles. Unagglutinated residual materials are washed through the membrane using a wash solution. This solution has a pH of from about 5 to about 10 and an ionic strength of at least about 0.25. Tracer is then determined either in the agglutinate or in the residual materials. The test kit includes the agglutination indicator reagent, the wash solution, and optionally an extraction composition.

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