Patent ID: 9651550
Date: 2017-05-16
CPC Classifications: G01N,Y10T

Claim:
1. A quantitative method for performing an automated diagnostic assay for an autoimmune 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, wherein the capture reagent is a biotinylated autoantigen; dispensing the capture reagent into the reaction cuvette using the first pipettor; incubating the capture reagent with the quantity of streptavidin-conjugated universal fluorescent-labeled magnetic microparticles to form a solid phase complex in the reaction cuvette; 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 create 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 comparing the second fluorescent signal with the first fluorescent signal to obtain a bead retention value; measuring a chemiluminescent signal associated with the transferred material; determining the response generated from the substrate, and comparing a generated bead retention adjusted relative light unit signal to a calibration curve relative light unit signal; 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 the reaction cuvette; wherein incubating the capture reagent with the streptavidin conjugated universal fluorescent-labeled magnetic microparticles includes incubating a capture reagent that is retained in a suspension by a reaction diluent including at least about 25% human serum albumin (HSA); wherein incubating the immune complex with the conjugate comprises incubating the immune complex that is retained in a suspension by a 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.