scholarly journals Introducing the new laboratory standard of HbA1c determination in Hungary

2011 ◽  
Vol 152 (14) ◽  
pp. 555-558
Author(s):  
Gabriella Bekő

A new laboratory standard, specific for HbA1c was prepared by the International Federation of Clinical Chemistry and Laboratory Medicine. Consequently, manufacturers will supply their calibrators with the International Federation of Clinical Chemistry and Laboratory Medicine standard. Laboratories in Hungary switch to this new method in April 1, 2011. After this date, results of HbA1c measurements will be reported in International Federation of Clinical Chemistry and Laboratory Medicine units (mmol/mol) and in the derived National Glycohemoglobin Standardization Program units (%) calculated by master equation from the International Federation of Clinical Chemistry and Laboratory Medicine/National Glycohemoglobin Standardization Program methods. Using the new standardization the HbA1c measurements will be traceable to the International Federation of Clinical Chemistry and Laboratory Medicine reference method and interlaboratory comparisons will be possible. Orv. Hetil., 2011, 152, 555–558.

2014 ◽  
Vol 67 (9-10) ◽  
pp. 339-344 ◽  
Author(s):  
Suncica Kojic-Damjanov ◽  
Mirjana Djeric ◽  
Nevena Eremic-Kojic

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%.


Author(s):  
International Federation of Clinica Jeppsson ◽  
Torsten Arndt ◽  
François Schellenberg ◽  
Jos P.M. Wielders ◽  
Raymond F. Anton ◽  
...  

AbstractAn alcohol-associated change in the serum transferrin glycoform pattern, carbohydrate-deficient transferrin (CDT), is used as a biomarker of chronic moderate to heavy alcohol consumption. A current limitation in CDT analysis is the lack of standardization, which hampers clinical and analytical comparison between studies. This situation prompted initiation of a Working Group (WG) on CDT Standardization under the auspices of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The standardization work aims to define and validate the analyte, select a reference method, work out procedures for the production of reference materials, and make suggestions for the clinical usage of CDT. The first recommendation of the WG is that disialotransferrin should be the primary target molecule for CDT measurement and the single analyte on which CDT standardization is based. It is further recommended that HPLC should be the analytical principle considered as the basis of an interim reference method until a suitable mass spectrometric reference method is established. In clinical use, CDT should be expressed in a relative amount (% CDT), to compensate for variations in the total transferrin concentration.Clin Chem Lab Med 2007;45:558–62.


2019 ◽  
Vol 57 (5) ◽  
pp. 623-632 ◽  
Author(s):  
Paul O. Collinson ◽  
Amy K. Saenger ◽  
Fred S. Apple ◽  

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.


Author(s):  
Katsuyuki Nakajima ◽  
Isao Koyama ◽  
Makoto Watanabe ◽  
Masakazu Nakamura ◽  
Yoshihiro Miyamoto ◽  
...  

Background The national programmes for the harmonization of haemoglobin A1c measurement in the US and Japan are based on differently designated comparison methods. The future basis for international standardization is expected to be the reference system developed by the International Federation of Clinical Chemistry (IFCC) Working Group on haemoglobin A1c Standardization. The aim of the present study is to compare the relationship between the IFCC reference method (RM) and Japanese Diabetes Society (JDS) RM used for the conversion to the National Glycohemoglobin Standardization Program (NGSP) values. Methods Three different method-comparison studies were performed. All blood samples were measured at the National Cerebral and Cardiovascular Centers (Lipid Reference Laboratories) that serve as Level 1 reference laboratories of the NGSP Network. Regression equations were calculated for the IFCC RM and JDS RM for the conversion to NGSP values. Results Differences were found between the haemoglobin A1c values of the IFCC RM and those of JDS. However, in all cases, the relationships of the IFCC RM and JDS RM were linear and commutable. The relationship is described by the following regression equations: NGSP-HbA1c = 0.915(IFCC-HbA1c) + 2.15% (r2 = 0.998); JDS/JSCC-HbA1c = 0.927(IFCC-HbA1c) + 1.73% (r2 = 0.997). Conclusion There is a firm and reproducible link between the IFCC and JDS-HbA1c values. However, the values calibrated by JDS RM were consistently and significantly higher than the IFCC values (0.1–0.2%) when used for conversion to the NGSP values.


2016 ◽  
Vol 44 (01) ◽  
pp. 19-25 ◽  
Author(s):  
G. Köller ◽  
K. Bassewitz ◽  
G. F. Schusser

ZusammenfassungZiel dieser Arbeit war, den Einsatz des Automaten IMMULITE 2000® mit einem immunometrischen Chemolumineszenz-Assay für die Bestimmung von adrenokortikotropem Hormon (ACTH), Insulin und Insulinwachstumsfaktor 1 (IGF-1) zu prüfen und entsprechende Referenzbereiche für Ponys zu berechnen. Material und Methoden: Nachmittags gewonnene Blutproben von 130 Ponys im Alter von 3–32 Jahren wurden auf Insulin, IGF-1 und ACTH untersucht. Die Referenzbereiche wurden nach der Richtlinie EP28-A3C der International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aus dem Jahr 2010 berechnet. Ergebnisse: Die Präzision für die Messungen an einem Tag lag für Insulin im Mittel bei 3,28%, für IGF-1 bei 1,84% und für ACTH bei 3,35%. Die Tag-zu-Tag-Präzision (Insulin: 3,45%; IGF-1: 2,89%; ACTH: 9,77%) wurde an drei aufeinanderfolgenden Tagen gemessen, wobei die Lagerung der Proben bei 4 °C erfolgte. Es zeigte sich kein signifikanter Verlust der Insulinaktivität bzw. der Konzentrationen von ACTH und IGF-1. Für Insulin und IGF-1 ergaben sich altersunabhängige Referenzbereiche (Insulin: 2,0–21,2 mU/l; IGF-1: 50,2–357,2 μg/l). Dagegen wurde für ACTH ein altersabhängiger Referenzbereich er - mittelt, der bei Ponys im Alter von 3–12 Jahren signifikant niedriger war (4,2–19,8 pg/ml) als bei Ponys im Alter von 13–32 Jahren (5,0–22,6 pg/ml). Schlussfolgerung: Das verwendete Analyseverfahren eignet sich für die Untersuchung von Serumproben von Ponys auf ACTH, IGF-1 und Insulin, doch wird der Einsatz bei der Insulinmessung durch die untere Nachweisgrenze von 2,0 mU/l limitiert. Klinische Relevanz: Die berechneten Referenzbereiche für Insulin und ACTH sind hilfreich für die Diagnostik und Verlaufskontrolle des equinen metabolischen Syndroms und der Pituitary Pars Intermedia Dysfunction (PPID).


2005 ◽  
Vol 24 (3) ◽  
pp. 157-170
Author(s):  
Nada Majkic-Singh

Medical biochemistry (synonyms: clinical chemistry or clinical biochemistry) in the terms of professional and scientific discipline, stems from and/or has developed along with the natural sciences and its influences (mathematics, physics, chemistry and biochemistry) and medical sciences as well (physiology, genetics, cell biology). As a scientific discipline, medical biochemistry studies metabolic processes of physiological and pathological changes with humans and animals. Applying analytical chemistry's and biochemistry's techniques enables medical biochemists to gain plenty of information related to diagnosis and prognosis which serve physicians to asses the gravity of illness and prescribe healing therapy. Therefore medical biochemistry is an integral part of modern medicine. This discipline was dubbed various, often confusing names such as pathology, physiology, clinical biology, clinical pathology, chemical pathology, clinical biochemistry, medical biochemistry, clinical chemistry and laboratory medicine, all depending on place of origin. The official, internationally accepted name - clinical chemistry, was mentioned for the first time in 1912 by Johan Scherer, who described his laboratory as Clinical Chemistry Laboratory (Klinisch Chemische Laboratorium) in the hospital Julius in Wurzburg in Germany. After creating national societies of clinical chemists, Professor Earl J. King of Royal Postgraduate Medical School from London incited an initiative to unite national societies into the organization with worldwide character - it was the International Association of Clinical Biochemists, monitored by the International Union for Pure and Applied Chemistry (IUPAC). On 24 July 1952 in Paris, a Second International Congress of Biochemistry was held. A year later, in Stockholm, the name of a newly formed association was altered into International Federation of Clinical Chemistry, which was officially accepted in 1955 in Brussels. Today this federation-s name is International Federation for Clinical Chemistry and Laboratory Medicine (IFCC). Right after the World War II our medical biochemists began to gather within their expert societies. Even before 1950 Pharmaceutical Society of Serbia hosted laboratory experts among whom the most active were Prof. Dr. Aleksandar Damanski for bromatology, Prof. Dr. Momcilo Mokranjac for toxicology and Docent Dr. Pavle Trpinac for biochemistry. When the Managing Board of the Pharmaceutical Society of National Republic of Serbia held its session on 22 December 1950, an issue was raised with reference to creation of a Section that would gather together the laboratory experts. Section for Sanitary Chemistry, combining all three profiles of laboratory staff, i.e. medical biochemists, sanitary chemists and toxicologists, was founded on 1st of January 1951. On 15 May 1955, during the sixth plenum of the Society of Pharmaceutical Societies of Yugoslavia (SFRY) held in Split, the decision was passed to set up a Section for Medical Biochemistry in SFDJ. The Section for Medical Biochemistry in SFDJ was renamed into Society for Medical Biochemistry of SFDJ based on the decision passed during the 16th plenum of SFDJ, held on 15 May 1965 in Banja Luka. Pursuant to the decision passed by SMBY on 6 April 1995 and based on the historic data, 15 May was declared as being the official Day of the Society of Medical Biochemists of Yugoslavia. The purpose of YuSMB (currently SMBSCG) is to gather medical biochemists who would develop and enhance all the branches of medical biochemistry in health industry. Its tasks are as following: to standardize operations in clinical-biochemical laboratories, education of young biochemists on all levels, encouraging scientific research, setting up of working norms and implementation, execution and abiding by the ethics codices with health workers. SMBSCG is to promote the systemized standards in the field of medical biochemistry with the relevant federal and republican institutions. SMBSCG is to enable exchange of experiences of its members with the members of affiliate associations in the country and abroad. .


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