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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However, this method is not very sensitive when there is more than one outlier. As whole-genome data becomes clinically available and more associations between genetic polymorphisms and laboratory test results are discovered, it will become possible to integrate the genetic information with RI values. The theory of reference values: Arch Pediatr Adolesc Med. There is opposition to this approach from some, as there is insufficient knowledge of the subjects and reliance on statistical methods to exclude the unhealthy subjects as explained in CA3.

The most useful parameter is the midpoint of the extracted data, which can be used to assess analytical or population bias by comparison with the corresponding midpoint of the data used to set the reference interval.

Jones G, Barker A. CA3 document; Defining, establishing and verifying reference intervals in the clinical laboratory: You may delete a document from your Alert Profile at any time. Modulation clai high-density lipoproteins in a population in Istanbul, Turkey with low levels of high-density lipoproteins.


Intra- and inter-individual biological variability of the subjects within the reference population may influence the determination of that RI. But, once Clai got to the sections with specific examples, the concepts were much easier to understand. Ceriotti F, Henny J. Although there has been increasing interest in this subject 7475this issue remains incomplete in the same way as for pediatric RIs. Based on this protocol a number of multicentric RI studies have been performed and common RIs have been reported.


Transference and Validation of Reference Intervals

Add to Alert PDF. This approach is valid only if there is a majority of unaffected results from the general practice population such that the healthy distribution of values can be clearly identified in the midst of a smaller number of the nonhealthy.

Statistical treatment of collected reference values. TateTina YenGraham R. Thus, the RI will not be sensitive to changes for that individual and, on average, for any individual and in this case, subject-based RIs are considered. Prerequisites for use of common reference intervals.

Reference intervals: current status, recent developments and future considerations

An analysis of transformations. It has also been reported that genetic and environmental factors are important in modulating HDL cholesterol concentrations in Turks Harmonization of c28a-3 quality indicators. A multicenter nationwide reference intervals study for common biochemical analytes in Turkey using Abbott analyzers.


An appraisal of statistical procedures used in derivation of reference intervals. To avoid confusion, the 2c8-a3 recommended reporting decision limits or RIs but not both, with a clear indication of which has been used.

Transference and Validation of Reference Intervals | Clinical Chemistry

The lower reference limits are estimated as the 2. Determining Laboratory Reference Intervals: Health is a relative condition lacking a universal definition.

The exclusion and partitioning criteria can be implemented appropriately through a well-designed questionnaire. The requirements of the central laboratory are also described in detail, including the method of cross-check testing between the central laboratory of each country and the local laboratories before the RIs can be applied Presentation of observed values related to reference values.

Advice on how to do this is found in guidelines from the CLSI. Complex reference values for endocrine and special chemistry biomarkers across pediatric, adult, and geriatric ages: Authors’ Disclosures or Potential Conflicts of Interest: Although indirect methods can be used as an alternative, the problem of valid RIs for specific age groups e.