Abstract: A glycated hemoglobin assay utilizes a simple procedure for the determination of standardized %GHb in whole blood samples correlated to the Diabetes Control and Complications Trial (DCCT). First, a lysed whole blood sample is incubated with a solid phase that is coupled with boronic acid or similar boronate compound through covalent linkage chemistries known in the art. Next, a labeled antibody to human hemoglobin is added and the resulting signal is directly proportional to the %GHb in the sample. The advantages of measuring %GHb using a single determination include high precision and, since the assay is easily automatable, high throughput. With automation, this assay can also be consolidated with other testing on one analyzer. The method according to the various embodiments of the invention thus eliminates the need for two measurements: one for GHb and another for total hemoglobin (THb).

Abstract: A glycated hemoglobin assay utilizes a simple procedure for the determination of standardized %GHb in whole blood samples correlated to the Diabetes Control and Complications Trial (DCCT). First, a lysed whole blood sample is incubated with a solid phase that is coupled with boronic acid or similar boronate compound through covalent linkage chemistries known in the art. Next, a labeled antibody to human hemoglobin is added and the resulting signal is directly proportional to the %GHb in the sample. The advantages of measuring %GHb using a single determination include high precision and, since the assay is easily automatable, high throughput. With automation, this assay can also be consolidated with other testing on one analyzer. The method according to the various embodiments of the invention thus eliminates the need for two measurements: one for GHb and another for total hemoglobin (THb).

Abstract: The present invention includes novel rubella assays employing a Rubella virus capture reagent and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing Rubella antibody may be contacted with the capture reagent to form a capture reagent/analyte complex. The complex is then contacted to the positively charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: The present invention includes novel digoxin assays employing a capture reagent, involving a first binding member conjugated to a polymeric anion substance, and a solid phase material containing a reaction site comprising a polymeric cation substance having a nitrogen content of at least about two percent. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: The present invention includes novel assays employing a capture reagent, involving a first specific binding member conjugated to a polymeric anion such as carboxymethylamylose, and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to/ the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. The use of carboxymethylamylose to prepare a suitably charged capture reagent provides a superior capture reagent that is capable of binding and retaining the analyte on the solid phase even in the presence of polyanionic non-specific binding blockers.