Evaluation of the performance and stability of a novel A1c-cellular control.

Corresponding Author: Kausik Das, Ph.D., Research and Development Division, Streck Inc., 7002 S. 109 St., La Vista, NE 68128; email address [email protected] Research shows lifestyle changes and regular monitoring of diabetes indices are the most effective means to manage diabetes.1,2 Measuring hemoglobin A1c (A1C) is an accepted means of diagnosis and a helpful indicator when monitoring diabetes status. Hemoglobin A1c analyzers are usually based on three analytical principles: highperformance liquid chromatography, immunoturbidimetry, and boronate affinity. The A1C values obtained from different analyzers often vary because of the differences in analytical principles and matrix effects.3 Thus a quality control that consistently provides similar A1C values within a relevant range across various analyzers would be helpful when correlating results from various methodologies. Clinical and Laboratory Standard Institute regulations state that control materials should be treated in the same manner as a patient specimen.4 A whole blood control would be ideal; however, the instability of whole blood and the unavailability of large volumes of diabetic blood, as well as ethical concerns, are major limitations. Streck A1c-Cellular®, a ready-to-use bi-level liquid control, resembles whole blood, as it contains intact red cells and is used in the same manner as a patient sample. In this letter, we describe the performance of this control across multiple analyzers and report the stability of the recovered A1C values and the stability of the intact red cells that constitute the control.