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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In addition, they may be collected in a defined order and may not be mutually independent. An initial assessment of whether methodology and xlsi traceability of the laboratory’s assays are similar to those used to establish the reference interval will prevent wasted efforts. International Organization for Standardization.

Reference Intervals for Serum Creatinine Concentrations. Arch Pediatr Adolesc Med. Pesce, PhD, another member of the subcommittee. Proteins and Clinical Mass Spectrometry: If three or four results lie outside the reference range, then another 20 samples must be collected.

Reference intervals: current status, recent developments and future considerations

Any 2c8-a3 bias will result in misclassification of too many patients. Common reference intervals the IFCC position. Published online Feb Add to Alert PDF. Rather, for assays with established traceability, traceable assays should be used to both set and use the interval 6.

Transference and Validation of Reference Intervals

In the protocol for multicenter studies 18cross-check testing is recommended to convert the RIs obtained from the multicenter study by the centralized assay to the values of each participating laboratory. This guideline recommends that each laboratory adopts existing RI values by performing an analysis to validate the transference of a RI reported by a manufacturer or other donor laboratory. However, a robust method with such a small number of reference subjects e.

The width of the reference range is altered by factors such as the regular use of medications or unrecognized subclinical diseases. National guidelines define a good value for someone who has his or her diabetes under control. Utility of panel of sera for alignment of test results in the worldwide multicenter study on reference values. Elevated hepatic lipase activity and low levels of high density lipoprotein in a normotriglyceridemic, nonobese Turkish population.


Pathology ; If three or more again fall outside these limits, the user should re-examine c288-a3 analytical procedures used and consider possible differences in the biological characteristics of the two populations sampled The consent form should state clearly that laboratory personnel are allowed to obtain specimens, and to use the associated laboratory values and questionnaire information for the determination of RIs Ozarda Ilcol Y, Diler A.

Multicenter reference interval studies The requirement that each clinical laboratory produce its own RIs is practically impossible for most clinical laboratories.

A study was made of the measurement clei 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 Preparation of individuals and collection of the specimens for the production of reference values. The jacknife, the bootstrap, and other resampling plans. Although some laboratories have performed local studies for their own use, there have also been multicenter studies performed with considerable numbers of subjects to establish useful RIs by laboratories in the Nordic countries 5051Spain 52Australia 53 cli, 54Asia 5556 and C28-z3 Both of these methods are known as direct sampling, which is the primary recommendation of the IFCC.

If the document is revised or amended, you will be cls by email. CLSI is a global nonprofit organization that promotes the development and use of oluntary consensus standards and guidelines within the health care community.

Clin Biochem ; Biological reference intervals and ISO Harmonization of pre-analytical quality indicators. The two most recent papers published by the C-RIDL include this strategy for the alignment of test results for the derivation of RIs 18 It has also been emphasised that as there is little control of the pre-analytical and analytical conditions, the indirect approach could be used for local situations or difficult groups of subjects such as neonates, children or the elderly, or as a means to confirm the goodness of the selected RI If a clinical laboratory changes the method used or wishes to apply RIs established by another laboratory which has used a different method, transference of the RIs can be implemented, rather than collecting samples from reference individuals to establish a RI for the new method.


Time for an Update The previous version of CA3, CA2, published infocused its reference interval calculations on laboratories that could collect samples from reference individuals.

Dybkaer R, Solberg HE. Thus, it discusses in detail techniques to use fewer samples, both to establish and to verify reference intervals. Reporting the correct gestational age-specific reference values can also improve the sensitivity of the RIs as mentioned before in this review by stratification of age and gender.

Several statistical methodologies have been proposed to be able to make the extremely important decision of whether or not to separate different groups. Scientific committee, Clinical Section. The Horn using Tukey method is a more sophisticated method, which includes Box-Cox transformation of the data to obtain Gaussian distribution followed by identification of the outliers in interquartile ranges IQR: Receive exclusive offers and updates from Oxford Academic.

Baadenhuijsen H, Smith CJ. Although it strongly endorses as the recommended number of reference samples, it recognizes that this is a high standard. Effects of outliers and nonhealthy individuals on reference interval estimation. 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 furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. As common standardization and traceability are crucial during production of reference values, each step of pre-analytical, analytical and statistical application follows a well-defined protocol.