Patent ID: 8058073

Claim:
A method for manufacturing and using an immunodiagnostic test card, said immunodiagnostic test card including at least one transparent column, said at least one transparent column initially containing at least one of a quantity of beads and gel material capable of trapping agglutinates produced by an agglutination reaction, said method comprising the steps of: providing indicia relative to said at least one transparent column of said immunodiagnostic test card, said indicia including a set of at least three parallel spaced markings in relation to said beads or gel material in said at least one transparent column, wherein said set of parallel spaced markings collectively define a grading scale defined by a plurality of visible adjacent grading zones with regard to agglutinates formed from an agglutination reaction; filling said at least one transparent column with at least one of beads and gel material wherein said indicia is used as a datum for determining the fill accuracy of said material; adding a quantity of patient sample to said at least one transparent column; mixing the patient sample with the contents of said at least one transparent column to produce an agglutination reaction; and assigning a grade to the agglutination reaction by visually detecting the presence or absence of agglutinates relative to said set of spaced markings, wherein said grading scale is defined between 0, indicative of a very strong negative reaction in which no agglutinates are formed and a pellet of cells are present below a lowermost visible grading zone and 4+, indicative of a very strong positive reaction in which all of the formed agglutinates are present above an uppermost visible grading zone based on the relative position of the formed agglutinates within the beads or gel material following said mixing step, said grade assigning step including the step of determining the position of the majority of formed agglutinates within a visible grading zone of said column and grading the reaction based on the location of said majority of formed agglutinates.