Laboratories that measure glycated hemoglobin (HbA1c) now have available a whole blood cell control material that has been calibrated for several major autoanalyzers.

HbA1c is a derivative of hemoglobin that is formed nonenzymically by reaction at the N terminus of the protein molecule with glucose. In the normal adult human such derivatives constitute a few percent of the total erythrocyte hemoglobin, the most abundant being hemoglobin A1c, which increases several fold in concentration in diabetes mellitus, and is assayed to monitor control of diabetes. Once a hemoglobin molecule is glycated, it remains that way. A buildup of glycated hemoglobin within the red cell, therefore, reflects the average level of glucose to which the cell has been exposed during its life-cycle. Measuring glycated hemoglobin assesses the effectiveness of therapy by monitoring long-term serum glucose regulation. The HbA1c level is proportional to average blood glucose concentration over the previous four weeks to three months.

The American Diabetes Association and the World Health Organization have suggested that an HbA1c level of 6.5% or more is an indicator of type II diabetes and an HbA1c level of between 5.7 and 6.4% is an indicator of pre-diabetes.

Streck, Inc. (Omaha, NE, USA), an industry leader in the development and manufacturing of products for clinical and research laboratories, has released its A1c-Cellular control product, the only HbA1c control on the market with intact red blood cells.

The A1c-Cellular control is convenient to use, as it does not require reconstitution. It controls the entire HbA1c assay procedure, including the lysing of the red blood cells—a step omitted with other controls. This important feature ensures the entire system—instrument and reagents—is working properly and providing accurate patient results.

The A1c-Cellular control has been calibrated and certified for use on many of the major clinical autoanalyzers including: the Abbott (North Chicago, IL, USA) ARCHITECT c Systems; the Beckman Coulter (Indianapolis, IN, USA) UniCel DxC 600/800; the Bio-Rad (Hercules, CA, USA) D-10/Variant II and Variant II Turbo; the Roche (Pleasanton, CA, USA) cobas INTEGRA/6000/c311; the Siemens (Malvern, PA, USA) Dimension Series; and the Tosoh (Grove City, OH, USA) A1c analyzer, HLC-723G7.

A1c-Cellular control is available in two clinically significant levels: 4%–7% HbA1c (Level 1) and 9%–13% HbA1c (Level 2).

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