scholarly journals Consensus Statement on the Worldwide Standardization of the Hemoglobin A1C Measurement: The American Diabetes Association, European Association for the Study of Diabetes, International Federation of Clinical Chemistry and Laboratory Medicine, and the International Diabetes Federation

Diabetes Care ◽  
2007 ◽  
Vol 30 (9) ◽  
pp. 2399-2400 ◽  
Author(s):  
Keyword(s):  
European Association ◽  
American Diabetes Association ◽  
Hemoglobin A1c ◽  
Consensus Statement ◽  
Clinical Chemistry ◽  
International Diabetes Federation ◽  
Laboratory Medicine ◽  
International Federation

scholarly journals A Review of the Challenge in Measuring Hemoglobin A1c

2009 ◽  
Vol 3 (3) ◽  
pp. 439-445 ◽  
Author(s):  
Cas Weykamp ◽  
W. Garry John ◽  
Andrea Mosca
Keyword(s):  
High Performance ◽  
Hemoglobin A1c ◽  
Consensus Statement ◽  
Clinical Chemistry ◽  
Metrological Traceability ◽  
International Diabetes Federation ◽  
The United States ◽  
Medical Laboratory ◽  
Patient Groups ◽  
The Difference

The attraction of the simple biochemical concept combined with a clinical requirement for a long-term marker of glycolic control in diabetes has made hemoglobin A1c (HbA1c) one of the most important assays undertaken in the medical laboratory. The diversity in the biochemistry of glycation, clinical requirements, and management demands has resulted in a broad range of methods being developed since HbA1c was described in the late 1960s. A range of analytic principles are used for the measurement of HbA1c. The charge difference between hemoglobin A0 and HbA1c has been widely utilized to separate these two fractions, most notably found these days in ion-exchange high-performance liquid chromatography systems; the difference in molecular structure (affinity chromatography and immunochemical methods) are becoming widely available. Different results found in different laboratories using a variety of HbA1c analyses resulted in the need for standardization, most notably in the United States, Japan, and Sweden. Designated comparison methods are now located in these three countries, but as they are arbitrarily chosen and have differences in specificity, results of these methods and the reference values and action limits of the methods differ and only harmonized HbA1c in specific geographic areas. A reference measurement system within the concept of metrological traceability is now globally accepted as the only valid analytic anchor. However, there is still discussion over the units to be reported. The consensus statement of the International Federation of Clinical Chemistry (IFCC), the American Diabetes Association, the International Diabetes Federation, and the European Association for the Study of Diabetes suggests reporting HbA1c in IFCC units (mmol/mol), National Glycohemoglobin Standardization Program units (%), and estimated average glucose (either in mg/dl or mmol/liter). The implementation of this consensus statement raised new questions, to be answered in a concerted action of clinicians, biochemists, external quality assessment organizers, patient groups, and manufacturers.

scholarly journals Glycated hemoglobin a1c as a modern biochemical marker of glucose regulation

2014 ◽  
Vol 67 (9-10) ◽  
pp. 339-344 ◽  
Author(s):  
Suncica Kojic-Damjanov ◽  
Mirjana Djeric ◽  
Nevena Eremic-Kojic
Keyword(s):  
Blood Glucose ◽  
Hemoglobin A1c ◽  
Glycated Hemoglobin ◽  
Clinical Chemistry ◽  
Microvascular Complications ◽  
Reference Method ◽  
Laboratory Medicine ◽  
International Federation ◽  
Glycated Hemoglobin A1c ◽  
Diagnostic Criterion

Glycated Hemoglobin Structure and Synthesis of Molecule. Glycated hemoglobin A1c, the major fraction of glycated hemoglobin, is formed by irreversible nonenzymatic glycation. Its concentration depends only on the life span of red blood cells and blood glucose levels. Clinical Significance of Glycated Hemoglobin A1c. It is the key parameter for monitoring the regulation of diabetes and for assessing the risk of microvascular complications. It is a diagnostic criterion for diabetes as well. Its concentration reflects the average value of blood glucose over the last two to three months. The estimated average glucose, a new parameter which facilitates the patient?s self-monitoring of diabetes, can be calculated from its value. Methods for Determining Glycated Hemoglobin A1c and their Standardization. Immunoassay and ion-exchange chromatography are commonly used methods for the glycated hemoglobin determination in routine laboratory practice. The advantage of immunoassay is that there is no need for the sample pretreatment in order to eliminate unstable glycated hemoglobin A1c intermediary forms, and the possibility of false positive results is lower. The current program of standardization requires traceability to the International Federation of Clinical Chemistry and Laboratory Medicine reference method. Reporting and Interpretation of Results of Glycated Hemoglobin A1c Determination. Glycated Hemoglobin A1c can be reported as % or as mmol/mol. In our country, it is recommended to use the International Federation of Clinical Chemistry and Laboratory Medicine units (mmol/mol). When interpreting the results, the potential causes of falsely high or low values must always be taken into consideration. Recommendations for Clinical Practice. Periodic determinations of glycated hemoglobin A1c are recommended for monitoring of diabetes regulation. Additionally, the determination is recommended for the diagnosis of diabetes. The target value for the prevention of microvascular complications is < 7% and the diagnostic criterion for diabetes is ? 6.5%.

scholarly journals High sensitivity, contemporary and point-of-care cardiac troponin assays: educational aids developed by the IFCC Committee on Clinical Application of Cardiac Bio-Markers

2019 ◽  
Vol 57 (5) ◽  
pp. 623-632 ◽  
Author(s):  
Paul O. Collinson ◽  
Amy K. Saenger ◽  
Fred S. Apple ◽  
Keyword(s):  
Cardiac Troponin ◽  
Task Force ◽  
Clinical Chemistry ◽  
Point Of Care ◽  
High Sensitivity ◽  
Laboratory Medicine ◽  
International Federation ◽  
Cardiac Biomarkers ◽  
Educational Materials ◽  
Extensive Information

AbstractThe International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) formed a Task Force on the Application of Cardiac Bio-markers (TF-CB) in 2008, re-designated in 2018 as a committee (C-CB), to produce educational materials on cardiac biomarkers. Established in June 2017, definitive tables covering the majority of high-sensitivity, contemporary and point-of-care (POC) cTn assays have been developed by the C-CB and are available on the IFCC website. These tables provide extensive information about assays’ analytical characteristics and encompass information on diagnostic discriminants, particularly the 99th percentiles, as provided by the manufacturers.

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