CELLULAR STANDARDS FOR GLYCATED HEMOGLOBIN AlC DETERMINATION

摘要

Disclosed are cellular hemoglobin AIc (Hb AIc ) normal and abnormal (high) controls for use in detecting Hb AIc levels. The present invention also relates to methods for generating cellular Hb AIc controls using red blood cells and methods for using the cellular controls. The present invention encompasses several methods for the preparation of Hb AIc cellular controls including: (1) a boronate method where the glycation occurs non-specif ically; (2) a stabilized diabetic blood method where the glycation occurs specifically on Hb AIc, and (3) the glycation of normal blood method that is achieved by controlling conditions such that glycation occurs predominantly on Hb AIc. These methods produce cellular Hb AIc controls with desirable stability and that can be detected on a variety of instruments. In preferred embodiments, the control contains intact erythrocytes .