Diabetes mellitus is a condition characterized by hyperglycemia resulting from the body’s inability to use blood glucose for energy. In Type 1 diabetes, the pancreas no longer makes insulin and therefore blood glucose cannot enter the cells to be used for energy. In Type 2 diabetes either the pancreas does not make enough insulin or the body is unable to use insulin correctly. The complications of diabetes involving the eyes, kidneys, nerves and the large blood vessels of the heart, brain and extremities are common to both forms of the disease. Diabetes mellitus affects more than 5% of the world population. The HbA1c assay provides a metric for blood sugar levels over the past 3 months from date of blood draw. HbA1c is detected utilizing ion-exchange chromatography. This technology provides both a numerical result and a visual picture of the separated hemoglobins, distinguishing hemoglobin fractions based on charge differences. According to the American Diabetes Association (ADA), the goal for most adults with diabetes is an A1c that is less than 7%. With regard to children, the ADA 2020 Standards of Care recommends a hemoglobin A1c of <7% for many children with type 1 diabetes (T1D), with an emphasis on target personalization.
At least one 5 mL lavender top EDTA tube to be shipped at cold (preferred) or room temperature. The sample can be drawn and processed same day at room temperature. If delay in processing is expected then the sample should be left at 2-8 °C. Samples left at 2-8 °C are best left unprocessed for maximum of 7 days. Samples are to be REJECTED if they arrive at room temperature 72 hours post collection, or refrigerated 7 days post collection. Grossly hemolyzed samples are unacceptable.
ion-exchange chromatography
| Diagnosis | A1C Level |
| Normal | below 5.7 percent |
| Prediabetes | 5.7 to 6.4 percent |
| Diabetes | 6.5 percent or above |