Second Edition (NCCLS document CA2) is written for users of diagnostic laboratory tests. It offers a .. CLSI Laboratories (PA) HA3. Procedures for the Collection of Arterial Blood Specimens; Approved Standard—. CLSI CA3. November Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third. For guidance on establishing or validating reference intervals, Dr. Horowitz recommends that a laboratory obtain a copy of CA3, which was.

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A multicentre study of reference intervals for haemoglobin, basic blood cell counts and erythrocyte indices in the adult population of the Nordic countries. More recently, Ichihara and Boyd recommended a partioning method on the basis of the magnitude of the standard deviations of test results named standard deviation ratio SDR Pathology ; Clin Chem ; In addition, the question of transference becomes one of comparability of the reference population Multicentric RIs studies are the most important development in the area of RIs.

The Experts Paul S. Therefore, preliminary information gathered from the manufacturer, external quality assurance EQA programs, and other c28-x3 data is a first step to determining an assay’s traceability claims and suitability for transfer of the reference interval.

Transference and Validation of Reference Intervals | Clinical Chemistry

The strength of the data lies in the large numbers per age and sex partition and the stringent exclusion of diseased individuals. The advantage of large, well-conducted direct studies is the well-defined reference population with exclusion of diseased subjects, optimum control of preanalytical variables, robust statistical analysis to remove outlier values, and narrow confidence limits around the obtained reference limits. However, this may depend on various factors such as analyte concentrations, different forms, or matrix issues, in particular for pediatric partitions Ideally, RIs are determined on the basis of a healthy population using direct methods 4.


They must understand the basic principles of how these values are derived.

Reference intervals: current status, recent developments and future considerations

Author information Article notes Copyright and License information Disclaimer. Partitioning of nongaussian distributed biochemical reference data into subgroups. Journal List Biochem Med Zagreb v. As a result, the entire medical care system will become more efficient.

Transference and Validation of Reference Intervals

The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. These comparisons must be performed using patient cls to ensure a valid comparison.

Solberg HE, Stamm D. A study was made of the measurement of three enzymes aspartate aminotransferase – AST, alanine aminotransferase – ALT and gamma-glutamyltransferase – GGT measured with commercial analytical systems according to the standard methods recommended by the IFCC The other prerequsites of multicenter studies can be summarized as a priori selection of reference subjects i.

Calculation of RIs includes parametric and nonparametric calculation methods, detection of outliers, partitioning, and confidence intervals. Received Oct 2; Accepted Dec You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. Specific RI values for pregnant women and for uncommon samples are also necessary.

Reference intervals: current status, recent developments and future considerations

Biochemical values in persons older than 82 years of age: By contrast, the hematology parameters lack certified reference materials, although several are traceable to reference measurement procedures, which has resulted in acceptable equivalence of measurement results between different platforms.


It has also been reported that genetic and environmental factors are important in modulating HDL cholesterol concentrations in Turks Need for revisiting the concept of reference values. However, as an alternative, indirect methods can be flsi for the pediatric group as recommended in the CA3 13 Whichever method is used in the calculation of the RIs, detection and exclusion of the outliers are very important to obtain reliable RIs.

Therefore, it would be better to report the population-based RIs only in the RI column in the laboratory results, and to state-the CDL clearly as a comment in the laboratory report, for example at the bottom of the report when a parameter has well-defined CDLs in the report.

Indirect estimation of clinical chemical reference intervals from hospital patient data. Establishing pediatric reference intervals: However, in the report example of the CA3, in the section of the medical decision limits, the CDLs of total cholesterol and high-density lipoprotein HDL cholesterol have been given in the cosi column as the RIs, which is confusing on the basis of terminology As these direct studies were well conducted and clai large sample size, the current problems in pediatric RIs could be resolved through evaluation and application of the findings.

C28-3 biological profile of hematologic markers across pediatric, adult, and geriatric ages: However, a robust method with such a small number of reference subjects e.