The tests in a clinical chemistry laboratory measure concentrations of biologically important ions salts and minerals, small organic molecules and large macromolecules primarily proteins. A 52yearold woman with a medical history of hepatitis b, hyperlipidemia, hypertension, anemia, and depression presented to the internal medicine clinic for a routine visit. If you could statistically determine the distribution of the well subjects, then you could, in principle, determine the reference interval without performing a reference interval study. Pdf distinguishing reference intervals and clinical decision limits.
For species without established reference intervals, one should refer to general publications and textbooks as a guideline only. Reference interval for clinical chemistry test parameters from apparently healthy individuals in southwest ethiopia article pdf available february 2020 with 72 reads how we measure reads. Gos paediatric reference ranges obtained from great ormond street hospital. These reference intervals will be useful for interpreting results of medical checkups at one year of age. Establishing reference intervals for clinical laboratory test.
Aug 01, 2015 although laboratories are well versed in method verification and validation to assess if methods are fitforpurpose, less importance is commonly put on selecting the most appropriate reference interval to determine whether an individual is healthy. Methods for estimating them are expensive, difficult to perform, often inaccurate, and nonreproducible. Clinical chemistry reference intervals of healthy adult populations in. Background clinical laboratory reference intervals ris are essential for clinical diagnosis, treatment and therapeutic monitoring. Reference intervals for eight enzymes in blood of adult females and males measured in accordance with the international federation of clinical chemistry reference system at 37c. The latest on reference values and reference intervals westgard. Learn vocabulary, terms, and more with flashcards, games, and other study tools. From 1987 to 1991, the international federation of clinical chemistry ifcc published a series of 6 papers, in which it was recommended that each laboratory. Pdf reference interval for clinical chemistry test. The clinical value of those results depend crucially on the reference intervals with which they are compared, and all efforts directed at ensuring analytically precise and accurate test results are, to a greater or lesser extent, in vain if the relevant. Authorized quality manager, labtests auckland chemical pathologist, labtests auckland august 2019 date. Rdw red cell distribution width reference values were established using adult animals 1 year.
An ri is intended to inform the clinical care provider that laboratory values within the interval indicate a nondiseased condition. Soldin et al10 that is now in its sixth edition and published by american association for clinical chemistry. They represented routine clinical chemistry assays commonly performed at the pamela youde nethersole eastern hospital pyneh. Establishing reference intervals in the coagulation laboratory. Mlt 230 clinical chemistry, unit 4 201229 flashcards. A computerized indirect hoffmann method was studied for accuracy and reproducibility. Protocols such as those of the international federation of clinical chemistry expert panel on theory of reference values 16 and the national committee for clinical laboratory standards 7 delineate comprehensive, systematic processes that use carefully selected reference sample groups to establish reference intervals. H pathology harmony reference range gsts guys and st thomas hospital na not applicable not available w all wales clinical biochemistry audit group. Pdf reference intervals of common clinical chemistry.
Harmonising reference intervals for three calculated. Clinical chemistry reference intervals veterinary medical teaching hospital university of california, davis analyte unit dog cat horse eq. Reference interval, hematology, chemistry, 1yearold, feeding. The reference interval ri is the most common support tool for the interpretation of clinical chemistry results. Transference and validation of reference intervals clinical. Mpv mean platelet volume foal reference values were established using animals reference interval, the most widely used tool for interpretation of patient test results. Effect of outliers and nonhealthy individuals on reference interval. Tietz textbook of clinical chemistry and molecular. See section 6 for more detail about specific analytes. Quality assurance and laboratory standard guidelines. Reference intervals for clinical and lab medicine introduction this routine calculates the sample size needed to obtain a specified relative width of a confidence interval about the limits of a reference interval calculated with a covariate such as age. The establishment of neuronspecific enolase reference. Guidelines for the determination of reference intervals ri in veterinary species.
Blood donors in hong kong gave permission for additional blood to be collected for reference interval testing. Values of the international federation of clinical chemistry and laboratory. Reference intervals are available for hematology and chemistry tests for dogs, cats, horses, cattle, goats and alpacas and blood gas and electrolyte intervals for dogs, cats, horses and cattle. Tietz textbook of clinical chemistry and molecular diagnostics is an internationally recognized definitive reference text for clinical laboratory scientists and chemical pathologists. Define the method used, the accuracy base, and analytical specificity. In the dialog box you identify the variable with the measurements. An introduction to reference intervals 1 some theoretical. Establishing reference intervals for clinical laboratory test results. The populationbased reference interval is the most widely used tool for interpretation of individual patient laboratory test results. Jul 10, 2008 calculations of reference intervals were performed by bootstrap estimation using refval 4.
Foal cow sheep pig goat donkey alpaca llama rhesus acthendogenous pmoll 6. To investigate and establish a reference interval ri of neuronspecific enolase nse in southwest chinas healthy population by using the laboratory information system database. Clinical diagnostic laboratory cbc reference intervals. We have blood gas and electrolyte ranges for dogs, cats, horses and cattle only. Read towards common reference intervals in clinical chemistry, clinical chemistry and laboratory medicine cclm on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Reference intervals of common clinical chemistry analytes for. Clinical chemistry is the branch of laboratory medicine that focuses primarily on molecules. Pdf reference intervals of common clinical chemistry analytes. Method specific reference intervals were established for twenty. Several initiatives have begun establishing harmonized reference intervals and recommending their use in clinical practice. Nov 20, 2017 rather, a common reference interval should be used to ensure consistent laboratory test result interpretation. The purpose of this work was to develop reference intervals for these key analytes that reflected the hospitals patient population after the architect became the test of record analytical system. Jan, 2015 it has been common aspiration of clinical chemists that laboratory test results and reference intervals should be comparable and independent of the medical laboratory that produced them.
Jan 17, 2017 secondary objectives were to establish agerelated reference intervals ri for both haematology and clinical chemistry variables and to evaluate the iron profile in newborn piglets without exogenous supplementation 5 days old and young pigs administered with exogenous iron within 3 days after birth 30 days old. When used for this purpose, the preferred approach is to use the central 95% of a normally distributed healthy population. These questions and many others are dealt with in the july special issue of clinical chemistry and laboratory medicine, cclm, on reference values and reference intervals volume 42, number 7, 2004, where many of the most outstanding scientists within the reference concept and related scientific areas introduce their thoughts, in order to. This fifth edition has been produced six years after the preceding one by the same editorial team, and is split into five main sections. Reference intervals for 33 biochemical analytes in healthy indian. Define the analyte measurand for which the reference interval is being established, the clinical utility, biological variation and major variations in form. The first 1 was an introduction to the theoretical concepts that underpin the significance, construction and use of reference intervals.
Towards common reference intervals in clinical chemistry. Reference values for clinical chemistry tests during normal pregnancy a larsson,a m palm,b lo hansson,a o axelssonb a department of medical sciences, clinical chemistry, university hospital, uppsala, sweden b department of womens and childrens health. These include initiatives in the nordic countries, australia and new zealand, united kingdom, and japan. A reference interval reference range, normal range can be calculated using the following 3 methods. All three of the approaches i show assume that the two distributions are gaussian. Scandinavian journal of clinical and laboratory investigation. Feb 01, 2011 read the clinical chemistry journals february 2011 clinical case study and student discussion.
What are the sources of reference intervals used by routine clinical laboratories. Reference values for clinical chemistry tests during normal. A notable exception is the manual of pediatric ris by. A reference interval ri 10 is a standard component of reporting a laboratory result and is important to transform a numerical value into clinically meaningful information. Locally established ris are required to correctly interpret clinical laboratory results. Reference intervals of common clinical chemistry analytes for adults in hong kong. The study used data collected retrospectively for 5 analytes. Armbruster2 1pamela youde nethersole eastern hospital, hong kong, china 2global scienti. The most critical steps in the determination of reference values are the selec. Establishing reference intervals for clinical laboratory. Version published in the journal veterinary clinical pathology. Vet clin pathol 414 2012 441453, 2012 american society for veterinary clinical pathology horn, p. Consider a measurement made on a population of individuals usually healthy patients.
In recent years, the international federation of clinical chemistry and laboratory medicine ifcc committee on reference intervals and. Reference intervals of hematology and clinical chemistry. We established reference intervals of hematology and clinical chemistry ana lytes from communitybased healthy children at one year of age. Describe the methods hba1c samples were run at the y hospital laboratory on the siemens dimension vista 1500, which is the project site, and at the x reference laboratory on the cobas integra roche modular 800. An ri as defined by ceriotti is an interval that, when applied to the population serviced by the laboratory correctly includes most of the subjects with characteristics similar to the reference group and excludes the. For species without established reference intervals, you should refer to general publications and textbooks as a guideline only. Kit reference range obtained from manufacturers instructions for use. Refval fulfils the recommendations of the international federation of clinical chemistry on the statistical treatment of reference values. Eight steps to method validation in a clinical diagnostic. In ethiopia, clinical laboratory test results are interpreted based on ris derived from a western population.
Recommended elements of a process for establishing a reference interval. Clinical chemistry uses many different methodologies, manual and fully. This document is based on the original recommendation of the expert panel on the theory of reference values of the international federation of clinical chemistry. Reference intervals for general clinical chemistry and hematology were defined. Estimating reliable paediatric reference intervals in.
Ifcc, international federation of clinical chemistry and laboratory medicine. Reference intervals for eight enzymes in blood of adult. Reference intervals are essential for clinical laboratory test interpretation and patient care. Methods a multicenter crosssectional study was conducted among.