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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Reference intervals: current status, recent developments and future considerations

Whether a test is normal or abnormal is perhaps the most important element of a laboratory test. Thus, if six laboratories participated, each could collect 20 samples to achieve the recommended samples, reducing the burden on each laboratory significantly. 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 Another point of discussion is the confusion which arises from RIs and clinical decision limits CDLs.

However, as an alternative, indirect methods can be used for the pediatric group as recommended in the CA3 13cli An appraisal of statistical procedures used in derivation of reference intervals.

Reference intervals: current status, recent developments and future considerations

CLSI is a global nonprofit organization that promotes the development and use of oluntary consensus standards and guidelines within the health care community. The most widely-used partitioning method is that of Harris and Boyd, in which the means and standard deviations of the subgroups are considered as a separate different standard deviation that may produce different limits Reference intervals are the most widely used decision-making tool in laboratory medicine and serve as the basis for many of the interpretations of pathology results.


National Center for Biotechnology InformationU. The exclusion and partitioning criteria can be implemented cclsi through a cllsi questionnaire. Statistical considerations for harmonization of the global multicenter study on reference values. The other prerequsites of multicenter studies can be summarized as a priori selection of reference subjects i. However, data for statistical analysis are very different: The most significant step in this area has been taken by Adeli et al. Use of total patient data for indirect estimation of reference intervals for 40 clinical chemical analytes in Turkey.

As a result, many patients are advised, incorrectly, to discontinue their medications, causing their cholesterol levels to return to their original abnormal levels and putting them at increased risk for coronary heart disease.

Pathology ; Once RIs have been obtained from a multicenter study, the next step in the transference process and potential v28-a3 of an interval is validation of the proposed RI, which takes account of pre-analytical, analytical, and local population differences The Experts Paul S. 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.

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 Oxford University Press is a department of the University of Oxford. Skip to main content. Statistical treatment of collected reference values. This standard is not included in any packages.


At a more complex level, Bhattacharya analysis can be used to assess the proposed intervals Samples from healthy cpsi with concentrations spanning the reference interval should be tested. The next step in the transference process and potential adoption of an interval is validation of the proposed reference interval, which takes into account preanalytical, analytical, and population differences.

Author information Article notes Copyright and License information Disclaimer. Using the same protocol in each laboratory c2-8a3. EQA samples were measured at the same time and mimicked the similarities and differences in reference intervals among the 5 assays 8. As a result, the entire medical care system f28-a3 become more efficient.

However, the extent of biological variability induced by genetic variants is cllsi low and there is often a lack of knowledge of the genetic status of the reference individuals.

Ceriotti F, Henny J. The requirements for conducting the multicenter study, phase by phase, are described in a new protocol which recommends that a practically attainable target sample size from each country is set at a minimum ofwhich is more than double the previously recommended minimum in the CA3 ; male and female. The concept of reference values. Abstract Reliable and accurate reference intervals RIs for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results.