Automated immunoanalyzer system for performing diagnostic assays for autoimmune and infectious diseases

A quantitative method for performing an automated diagnostic assay for an infectious disease comprising:

• dispensing a quantity of streptavidin-conjugated universal fluorescent-labeled magnetic microparticles into a reaction cuvette within a reaction rotor of an immunoanalyzer instrument using a first pipettor;
• measuring a first fluorescent signal associated with the quantity of streptavidin-conjugated universal fluorescent-labeled magnetic microparticles through an optics pipette;
• selecting a capture reagent suitable for performing the diagnostic assay;
• dispensing the capture reagent into the reaction cuvette using the first pipettor;
• incubating the capture reagent with the quantity streptavidin-conjugated universal fluorescent-labeled magnetic microparticles to form a solid phase complex in the reaction cuvette, wherein the capture reagent is a biotinylated infectious disease antigen;
• washing the solid phase complex to remove excess capture reagent;
• dispensing a serum sample into the reaction cuvette using a second pipettor;
• incubating the solid phase complex with the serum sample to form an immune complex;
• washing the immune complex to remove any unbound sample;
• dispensing a conjugate into the reaction cuvette using a third pipettor;
• incubating the immune complex with the conjugate to form an immune-conjugate complex;
• washing the immune-conjugate complex to remove any unbound conjugate;
• introducing a substrate capable of generating a quantifiable response using the third pipettor;
• transferring the substrate and immune-conjugate complex from the reaction rotor to an optics box using the optics pipette by aspirating the substrate and immune-conjugate complex from the reaction cuvette into the optics pipette;
• measuring a second fluorescent signal associated with the transferred material through the optics pipette and calculating a ratio of the first fluorescent signal to the second fluorescent signal to obtain a bead retention ratio;
• measuring a chemiluminescent signal in the transferred material;
• determining the response generated from the substrate;
• and
• adjusting the quantifiable response for bead retention by:
• adjusting the quantified chemiluminescent signal by the bead retention ratio to calculate a reported value, wherein one or more of the washing steps include washing the solid phase, immune, and/or immune-conjugate complexes by magnetically sequestering the solid phase, immune, and/or immune-conjugate complexes being washed within a confined area of a reaction cuvette;
• wherein the step of incubating the solid phase complex with the serum sample comprises binding an infectious agent-specific human IgG, IgM, or IgA present in the serum sample to the biotinylated capture reagent;
• wherein the step of incubating the capture reagent with the streptavidin-conjugated universal fluorescent-labeled magnetic microparticles includes incubating the capture reagent that is retained in a suspension by a reaction diluent including at least about 25% human serum albumin (HSA);
• wherein the step of incubating the immune complex with the conjugate comprises incubating the immune complex that is retained in a suspension by the conjugate diluent including no more than about 5% polyethylene glycol;
• and wherein horseradish peroxidase (HRP) is used as an indirect label when washing the immune complex to remove unbound sample.