Hemoglobin A1c: standardization, analytical performance and interference of Hb-variants.

Date:  December 04, 2020

Time: 5:00am PST, 2:00pm CET

Diabetes Mellitus has become a worldwide epidemic, affecting approximately 425 million people. Unfortunately, one in two patients remains undiagnosed. HbA1c can play a major role in finding these patients but this requires standardization of HbA1c. Standardization is important for optimal clinical use of HbA1c (e.g. uniform clinical guidelines, uniform reference values, comparison of scientific studies). HbA1c results of any laboratory anywhere in the world and irrespective the routine method used, should be the same. There are two key groups driving standardization and quality: the National Glycohemoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) standardization program. The IFCC Reference Measurement Procedure for HbA1c is the analytical anchor for the worldwide standardization of all routine HbA1c assays. Both models will be explained in this presentation. Currently there are more than 100 HbA1c methods/platforms available based on 5 major method principles. HPLC was called the golden standard for HbA1c as this method was used in the DCCT and UKPDS study. Many medical doctors still believe that HPLC is the golden standard for HbA1c which is not true as the analytical performance of many other routine methods has improved considerably which can be proven by looking at the results of external quality schemes. In this presentation I will focus on standardization, different method principles for HbA1c, interference of Hb-variants and how the different HbA1c methods perform in external quality schemes.

Learning Objectives:

• Learn about Harmonization and Standardization of HbA1c test methods
• Gain insights on the different HbA1c methodologies used in laboratories
• Understand causes of Interference in HbA1c assays
• Discover analytical performance of the different HbA1c methodologies using EQA Samples

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