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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The width of the reference range is altered by factors such as the regular use of medications or unrecognized subclinical diseases. In the CA3 guideline, non-parametric CIs are given from the observed values corresponding to certain rank numbers from Reed et al.

The classical cascade is defined from reference individuals, a reference sample group, reference values, reference distribution, reference limits and RIs. With the implementation of a common protocol and SOPs, the utility of a panel of sera was indicated for the alignment of test results among laboratories in multicenter studies Elevated hepatic lipase activity and low levels of high density lipoprotein in a normotriglyceridemic, nonobese Turkish population.

The expected information derived from the combination of assay and reference interval must meet the appropriate clinical sensitivity and specificity for each test. It is vital that a clear distinction is made between RIs and CDLs to allow optimal use of laboratory tests and avoid misdiagnosis. Statistical considerations for harmonization of the global multicenter study on reference values.


Validating common reference intervals in routine laboratories. The next step is to perform a method comparison study with another laboratory that has the setup assays, according to CLSI EPA3 7to determine the statistical validity of a reference interval transfer.

Influence of statistical method used on c,si resulting estimate c28-w3 normal range. However, this method is only appropriate for analytes with a Gaussian distribution with subclasses, where the values are of similar size and standard deviation.

Reference intervals: current status, recent developments and future considerations

Biological variations and genetic reference values for apolipoprotein E serum concentrations: Written informed consent from participants is needed from each reference clsk who agrees to participate in the study. Journal List Biochem Med Zagreb v. The exclusion and partitioning criteria can be implemented appropriately through a well-designed questionnaire. TateTina YenGraham R.

Transference and Validation of Reference Intervals | Clinical Chemistry

Before the calculation of intervals, subjects were first excluded according to various parameters including increased body mass index, history of chronic or metabolic disease, acute illness, or use of prescribed medication a month before sample collection.

The CA3 guideline allows for subjective validation of a RI by laboratory assessment of population demographics and pre-analytical and analytical parameters. The reference individuals form the reference sample group for measurement of the values from the reference population. Medical laboratories—particular requirements for quality and competence. National guidelines define a good value for someone who has his or her diabetes under control.

Ichihara K, Boyd J. These comparisons must be performed using patient samples to ensure a valid comparison. Scand J Clin Lab Invest. 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.


Various methods may be used for the selection of a group of healthy individuals from a general hospital population and reference values are calculated from hospital data using statistical methods, such as Bhattacharya analysis c,si and some modifications of the method 25 This article has been cited by other articles in PMC. The nonparametric method of estimation does not assume the probability distribution of the observed reference values 7.

A simple but effective method for the detection of outliers is visual inspection of clso data. Future studies should focus more specifically on the genetic effects on RIs and generate genotype-specific RIs. However, in the report clsu of the CA3, in the section of the medical decision limits, the CDLs of total cholesterol and high-density lipoprotein HDL c28-q3 have been given in the same column as the RIs, which is confusing on the basis of terminology The theory of reference values: Prossesing data for outliers.

Both of these methods are known as direct sampling, which is the primary recommendation of the IFCC.