The IFCC recommendation on estimation of reference intervals. The RefVal Program

2004 ◽  
Vol 42 (7) ◽  
Author(s):  
Helge Erik Solberg
Keyword(s):  
Statistical Methods ◽  
Reference Values ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Reference Intervals ◽  
International Federation

AbstractThe International Federation of Clinical Chemistry (IFCC) published between 1987–91 a series of six recommendations on reference values in laboratory medicine. This paper reviews the history and scope of the fifth part of these recommendations. This fifth recommendation deals with statistical methods used for analysis of reference values and estimation of reference intervals. The RefVal program, which implements the recommended method, is also described.

scholarly journals Establishment of Reference Intervals for Blood Urea Levels in Young Prospective Medical Students Undergoing Health Checkup at BPKIHS, Dharan, Nepal

1970 ◽  
Vol 8 (2) ◽  
pp. 126-129
Author(s):  
KD Mehta ◽  
AK Nepal ◽  
AK Jha ◽  
BK Lal Das ◽  
M Lamsal ◽  
...  
Keyword(s):  
Reference Values ◽  
Clinical Chemistry ◽  
Sampling Technique ◽  
Laboratory Medicine ◽  
Reference Intervals ◽  
International Federation ◽  
Healthy Population ◽  
Single Individual ◽  
Health Checkup ◽  
Diacetyl Monoxime

Background: Reference values or reference intervals are set of values of a certain type of quantity obtainable from a single individual or a group of individuals corresponding specific description.Objective: This study highlights the approach for determining the reference intervals for blood urea in a healthy population and establishes its upper and lower reference limits.Subjects and methods: A descriptive study was carried out in the Department of Biochemistry B. P. Koirala Institute of Health Sciences from June 2009 to August 2009. International federation of Clinical Chemistry and Laboratory Medicine (IFCC) priori sampling technique was used. Blood urea was estimated by diacetyl monoxime (DAM) and Glutamate Dehydrogenase (GLDH) kinetic methods. Reference intervals were defined as mean ± 1.96 SD. Mean and standard deviation for blood urea values were expressed as descriptive statistics.Results: The study included 60 individuals (36) 63% males and (24) 37 % females. Blood urea values by GLDH kinetic and DAM methods were 22.07 ± 5.6 mg/dl and 27.1 ±8.79 mg/dl respectively. Reference values of blood urea by GLDH kinetic and DAM methods were 16-28 mg/dl and 18-36 mg/dl respectively.Conclusions: This study highlights the establishment of reference intervals of blood urea levels from a healthy population. The reference intervals would enable the laboratory personnel and the clinicians to interpret the medical data.Health Renaissance, May-Aug 2010; Vol 8 (No.2):126-129  

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.

Referenzbereiche von Insulin, insulinähnlichem Wachstumsfaktor 1 (IGF-1) und adrenokortikotropem Hormon bei Ponys

2016 ◽  
Vol 44 (01) ◽  
pp. 19-25 ◽  
Author(s):  
G. Köller ◽  
K. Bassewitz ◽  
G. F. Schusser
Keyword(s):  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
International Federation ◽  
Pars Intermedia ◽  
Klinische Relevanz

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).

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

2011 ◽  
Vol 152 (14) ◽  
pp. 555-558
Author(s):  
Gabriella Bekő
Keyword(s):  
Master Equation ◽  
Clinical Chemistry ◽  
Reference Method ◽  
Laboratory Medicine ◽  
International Federation ◽  
New Method ◽  
Interlaboratory Comparisons

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.

Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?

2012 ◽  
Vol 50 (5) ◽  
Author(s):  
Mauro Panteghini ◽  
Ferruccio Ceriotti
Keyword(s):  
Reference Values ◽  
Reference System ◽  
Laboratory Medicine ◽  
Reference Intervals ◽  
Multicenter Studies ◽  
Reference Measurement ◽  
Measurement Systems ◽  
Experimental Protocols ◽  
Definition Of ◽  
Result Interpretation

AbstractAn issue associated with standardization efforts is the need to develop useful reference intervals (RI). Lack of proper RI may hamper the implementation of standardization in Laboratory Medicine as standardization can modify analyte results and, without adequate RI, this can impair the result interpretation. Once defined, RI obtained with analytical procedures that produce results traceable to the corresponding reference system can be transferred among laboratories, providing that they use commercial assays that produce results traceable to the same reference system and populations have the same characteristics. Multicenter studies are needed for a robust definition of traceable RI, using experimental protocols that include well defined prerequisites. Particularly, employed methods must produce results that are traceable to the reference system for that specific analyte. Thus, the trueness of laboratories producing reference values should be verified and, if necessary, experimental results corrected in accordance with correlation results with the selected reference. If requirements in the adoption of traceable RI are fulfilled, the possibility of providing RI that are applicable to any laboratory, able to produce results traceable to the reference system, is realistic. The definition of traceable RI should hopefully cause the disappearance of different RI employed for the same analyte, providing more effective information to clinicians.

Production of gender-specific morning salivary cortisol reference intervals using internationally accepted procedures

2004 ◽  
Vol 42 (12) ◽  
Author(s):  
Rajan S. Patel ◽  
Steve R. Shaw ◽  
Halena MacIntyre ◽  
Gerald W. McGarry ◽  
A. Michael Wallace
Keyword(s):  
Salivary Cortisol ◽  
Reference Data ◽  
Clinical Chemistry ◽  
Reference Intervals ◽  
International Federation ◽  
Adrenal Function ◽  
Biologically Active ◽  
Males And Females ◽  
Gender Specific ◽  
Free Plasma

AbstractBackground: Salivary cortisol concentrations correlate well with biologically active unbound free plasma cortisol concentrations. Despite its practical and analytical advantages, salivary cortisol measurement has been used mainly as a research tool rather than for the routine evaluation of adrenal function. This may be partly explained by the lack of robust reference data in the literature.Methods: Using the recommended procedures for the production of reference intervals published by the International Federation of Clinical Chemistry, we aimed to produce morning salivary cortisol reference intervals for males and females. Salivary cortisol was measured in 496 specimens collected from 248 reference individuals (128 males, median age 41years, range 16–86; and 120 females, median age 44years, range 16–98) attending an otorhinolaryngology clinic. Reference individuals mailed saliva specimens sampled on two consecutive mornings to our laboratory, where cortisol concentrations were measured.Results: Statistical analysis showed no significant correlation with age or body mass index. The following 95% gender-partitioned reference intervals were produced: males 10.9–40.3nmol/l; and females 9.3–40.3nmol/l.Conclusion: Knowledge of these salivary cortisol reference intervals helps us monitor the adrenal function of outpatients using topical intranasal glucocorticoids for rhinosinusitis.

scholarly journals Society of medical biochemists of Serbia and Montenegro: 50 years anniversary

2005 ◽  
Vol 24 (3) ◽  
pp. 157-170
Author(s):  
Nada Majkic-Singh
Keyword(s):  
Cell Biology ◽  
Clinical Biochemistry ◽  
Health Workers ◽  
International Association ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Scientific Discipline ◽  
International Federation ◽  
Chemistry Laboratory ◽  
Pharmaceutical Society

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. .

Mangankonzentrationen im Vollblut, Plasma und Serum adulter Warmblutpferde an 3 Standorten in Deutschland

2021 ◽  
Vol 49 (04) ◽  
pp. 234-246
Author(s):  
Elena Theiner ◽  
Corinna Weber ◽  
Elisabeth Müller ◽  
Monica Venner ◽  
Ingrid Vervuert
Keyword(s):  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
International Federation ◽  
Klinische Relevanz ◽  
Icp Ms

Zusammenfassung Ziel Etablierung von Referenzintervallen für Mangan (Mn) im Serum, Plasma und Vollblut bei adulten, gesunden Warmblutpferden mit bekannter Mn-Aufnahme und Vergleich von 2 analytischen Methoden der Mn-Bestimmung im Blut. Material und Methoden Zwischen Mai 2018 und November 2019 erfolgte auf 3 Gestüten bei 270 gesunden Pferden im Alter von 3–25 Jahren eine einmalige Blutprobenentnahme. In Vollblut, Plasma (Antikoagulans jeweils Lithium-Heparin [LH]) und Serum wurden die Mn-Konzentrationen mittels Massenspektrometrie mit induktiv gekoppeltem Plasma (ICP-MS) sowie mittels Atomabsorptionsspektrometrie (AAS) bestimmt. Die Referenzintervalle für jedes Substrat wurden nach den Empfehlungen der International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) und des Clinical and Laboratory Standards Institute (CLSI) berechnet (Bereich zwischen 2,5- und 97,5-Perzentil der analysierten Mn-Blutkonzentration). Zeitgleich mit der Blutprobenentnahme wurden repräsentative Futterproben entnommen, um den Mn-Gehalt der korrespondierenden Fütterung zu bestimmen. Ergebnisse Die Pferde zeigten im Vollblut mit einer medianen Mn-Konzentration von 12,4 µg/l (Referenzintervall: 4,99–25,1 µg/l [AAS]; 5,99–25,3 µg/l [ICP-MS]) signifikant höhere Mn-Konzentrationen (p < 0,0001) als im korrespondierenden Serum (Median: 1,65 µg/l, Referenzintervall: 0,60–3,50 µg/l [AAS]; 1,11–2,96 µg/l [ICP-MS]) oder LH-Plasma (Median: 1,35 µg/l, Referenzintervall: 0,22–2,68 µg/l [AAS]; 0,59–2,45 µg/l [ICP-MS]). Im Methodenvergleich ergaben sich für LH-Plasma und Serum zwischen der AAS und der ICP-MS statistisch signifikante Abweichungen in den Mn-Bestimmungen, wohingegen sie für das Vollblut vergleichbare Ergebnisse lieferten. Schlussfolgerung und klinische Relevanz Vollblut weist durchschnittlich 10-fach höhere Mn-Konzentrationen auf als Serum oder LH-Plasma. Bei der Bewertung von Mn-Konzentrationen im Blut muss daher berücksichtigt werden, welches Probenmaterial analysiert wurde und welche Methode zur Anwendung kam, da in Serum und Plasma zwischen AAS und ICP-MS relevante Unterschiede auftreten können.

International Osteoporosis Foundation and International Federation of Clinical Chemistry and Laboratory Medicine Position on bone marker standards in osteoporosis

2011 ◽  
Vol 49 (8) ◽  
Author(s):  
Samuel Vasikaran ◽  
Cyrus Cooper ◽  
Richard Eastell ◽  
Andrea Griesmacher ◽  
Howard A. Morris ◽  
...  
Keyword(s):  
Fracture Risk ◽  
Type I Collagen ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
International Federation ◽  
Bone Marker ◽  
Bone Resorption Marker ◽  
Type I ◽  
International Osteoporosis Foundation ◽  
Treatment Research

AbstractThe International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Bone Marker Standards (WG-BMS) has evaluated the clinical potential of bone turnover markers (BTMs) in the prediction of fracture risk and for monitoring treatment. Research evidence suggests that BTMs may provide information on fracture risk independently from BMD, so that fracture risk prediction might be enhanced by their inclusion in assessment algorithms. The potential use of BTMs to predict the response to treatments for osteoporosis in the individual patient is also of great interest. Treatment-induced changes in specific markers account for a substantial proportion of fracture risk reduction. However, there is still a need for stronger evidence on which to base practice in both situations. IOF/IFCC recommends one bone formation marker (serum procollagen type I N propeptide, s-PINP) and one bone resorption marker (serum C-terminal cross-linking telopeptide of type I collagen, s-CTX) to be used as reference markers and measured by standardised assays in observational and intervention studies in order to enlarge the international experience of the application of markers to clinical medicine and to help resolve uncertainties over their clinical use.

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