15 Feb The CA3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of. 6 Apr 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—. 1 Feb The previous version of CA3, CA2, published in , focused its reference interval calculations on laboratories that could collect.

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Elevated hepatic lipase activity and low levels of high density lipoprotein in a normotriglyceridemic, nonobese Turkish population. Although indirect methods can be used as an alternative, the problem of valid RIs for specific age groups e. Clinical chemistry reference values for year-old apparently healthy persons.

Reference intervals: current status, recent developments and future considerations

Because of the importance of harmonizing pre-analytical phase of the total testing process, an effort has been made by the European Federation for Clinical Chemistry and 2c8-a3 Medicine EFLM Working Group for Preanalytical Phase WG-PRE to support the worldwide harmonization of c82-a3 coding for blood collection tube closures 31 Need for revisiting the concept of reference values.

Physiology and its Importance for Reference Intervals. The most suitable transformation method must be selected e. Journal List Biochem Med Zagreb v.

This guideline recommends that each laboratory adopts existing RI values by performing an analysis to vlsi the transference of a RI reported by a manufacturer or other donor laboratory. It is vital that a clear distinction is made between RIs and CDLs to allow optimal use of laboratory tests and avoid misdiagnosis. Baadenhuijsen H, Smith CJ.

Other researchers favour the indirect method as the c2-8a3 are clinically relevant and much simpler for an individual laboratory to implement than the time-consuming direct a priori method, which requires considerable data and professional input 28 Another point of discussion is the confusion which arises from RIs and clinical decision limits CDLs. The Asian project for collaborative derivation of reference intervals: The linear structural relationship reduced major axis regression is used to convert the RIs.


Various methods may be used for cksi 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 24 and some modifications of the method 25 Distribution of creatine kinase in the general population: By employing the strategies discussed c28-a CA3, the laboratory can have more confidence in the reference intervals it reports with the test results.

My laboratory uses the techniques in the document all the time. Harmonization of pre-analytical quality indicators.

Reference intervals: current status, recent developments and future considerations

Health is a relative condition lacking a c28–a3 definition. Reporting of the test results to each laboratory 2. Clinical necessity of partitioning of human plasma haptoglobin reference intervals by recently-discovered rs But laboratories typically spend relatively little time making sure reference intervals given by manufacturers apply to their populations.

But, once I got to the sections with specific examples, the concepts were much easier to understand. The steps for the scheme of a multicenter study when all the samples from healthy individuals are collected in the participating laboratories and sent to the central laboratory for analysis are summarised in Table 1.

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

Whichever method is used in the calculation of clsii RIs, detection and exclusion cli the outliers are very important to obtain reliable RIs.

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. However, a robust method with such a small number of reference subjects e.

Use of total patient data for indirect estimation of reference intervals for 40 clinical chemical analytes in Turkey. 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 Author information Article notes Copyright and License information Disclaimer.

Inherent biological variation and reference values. Colour coding for blood collection tube closures-a call for harmonisation. Published online Feb The nonparametric method of estimation does not assume the probability distribution of the observed reference values 7. The concept of reference values. Normal values and statistics.


Close mobile search navigation Article navigation. This problem can be overcome by gathering large populations of reference individuals 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.

Stratification by age and gender is the minimum pre-requisite and other means include race, ethnicity, body mass index or nutritional habits Statistical criteria for separate reference intervals: A fundamental issue is the number of samples needed to dlsi the baseline value.

Reading this document and following the guideline will help you derive appropriate reference intervals. Whether a test is normal or abnormal is perhaps the most important element of a laboratory test.

In addition, they may be collected in a defined order and may not be mutually independent. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations.

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 c8-a3 limits and partitioning by genetic effects on RIs.

Generally, the pre-analytical considerations involve biological i. Solberg HE, Stamm D. These limits then define the RI 3. When evaluating 20 samples, if no more than two results are outside the proposed reference interval range, it is statistically valid for the laboratory c8-a3 adopt the proposed reference interval as its own. National Center for Biotechnology InformationU. Related articles in Google Scholar. Therefore, it becomes very difficult to differentiate the effects of age, aging or a pathological condition.