Date: May 18, 2021
Time: 5:00am PST, 2:00pm CEST
Since its discovery in the late 60s, HbA1c, the major form of glycated haemoglobin, has been widely used in laboratories as a key biomarker of glycemic control in patients with diabetes over the four to eight weeks preceding blood collection.
Many methods based on different principles (ion exchange HPLC, capillary electrophoresis, immunoassay, affinity, enzymatic methods) have been developed for assaying HbA1c, necessitating an international standardization which was achieved by IFCC in the 2000s. All HbA1c methods are now traceable to the IFCC reference measurement procedure, and values of calibrators are assigned by an international network of reference laboratories. The development of external quality assessment schemes together with the standardization process have deeply improved the quality of results.
Meanwhile, several interlaboratory trials have shown that an important point in external quality assessment was the use of commutable control samples (same behavior as fresh whole blood from patients) in order to clearly assess the quality of the methods.
Most of the analytical challenges of HbA1c assays have been addressed, especially interferences (labile HbA1c or carbamylated Hb). However, different clinical situations need to be carefully considered like chronic kidney disease, because of the modifications of red blood cell lifespan due to chronic anemia and to the possible administration of erythropoietin, and of the occurrence of competing processes like carbamylation. Another situation is the presence of a hemoglobin variant.
The interference of the major variants has been well documented, but many less common variants may be encountered that interfere positively or negatively with results.
Finally, besides its role as gold standard in the survey of glycemic control, HbA1c is now used in many countries as a tool for diabetes diagnosis and/or screening, being interesting for its lower variability than glucose and achievable without fasting.
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