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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If a clinical laboratory changes the method used or wishes to apply RIs established by another laboratory clis 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. 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.

Protocol and standard operating procedures for common use in wordwide multicenter study on reference values. Jones G, Barker A.

Pediatric and geriatric reference intervals As the concentrations of many routinely measured analytes vary significantly with growth and development, the use of inappropriate pediatric RIs can result in mis-diagnosis and mis-classification of disease. Physiology and its Importance for Reference Intervals. On occasion, data from multiple laboratories, lcsi strict quality assurance guidelines, can be pooled. Therefore, it is unnecessary to establish a reference interval.

Written informed consent from participants is needed from each reference individual who agrees to participate in the study. This method can provide the reference limits from a limited number of observations using only 20 subjects The theory of reference values: Modulation csli high-density lipoproteins in a population in Istanbul, Turkey with low levels of high-density lipoproteins. Turks have distinctively low concentrations of HDL cholesterol, associated with elevated hepatic lipase activity and fasting triglyceridemia Statistical criteria for separate reference intervals: C8-a3 fundamental issue is the number of samples needed to define the baseline value.


The RIs for uncommon sample types [e. Published clsl Feb Use of total patient data for indirect estimation of reference intervals for 40 clinical chemical analytes in Turkey.

Reference intervals: current status, recent developments and future considerations

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 As a result, the entire medical care system will become more efficient.

In a posteriori sampling, the exclusion criteria are applied after the sampling. Horowitz recommends that a laboratory obtain a copy of CA3, which was developed by internationally recognized experts and scientists from regulatory bodies, diagnostic laboratories, and the in vitro diagnostic industry.

As laboratories put new test systems into use, they are required by accreditation and certification bodies to verify or establish performance specifications, including reference ranges. Whichever method is used in the calculation of the RIs, detection and exclusion of the outliers are very important to obtain reliable RIs. Ideally, RIs are determined on the basis of a healthy population using direct methods 4.

Distribution of creatine kinase in the general population: Using the same protocol in each laboratory e. The lower reference limits are estimated as the 2.

J Clin Chem Clin Biochem. Laboratory reference intervals during pregnancy, delivery and the early postpartum period. The C-RIDL recently published two papers including a protocol and comprehensive standard operating procedures SOPs for multicenter RI studies 18with indication of the utility of a panel of sera for the alignment of test results among laboratories in multicenter studies This method is an iterative approach for the derivation of multiple reference RIs simultaneously, when no exclusion of values has been made in the initial computation of the RIs.


Oxford University Press is a department of the University of Oxford. Although the CA3 recommends the nonparametric calculation method, the RIs calculated by the parametric and nonparametric methods were compared in the recent IFCC, C-RIDL study which concluded that the results of the two methods are very close and parametric methods can also be used as a first choice The results of measurements on these samples for a given analyte will produce a temporal series, forming a baseline against which future results will be judged.

Reference intervals: current status, recent developments and future considerations

Prerequisites for use of common reference intervals. The steps for the scheme of a multicenter study when all the samples from healthy individuals are collected in the c28-aa3 laboratories and sent to the central laboratory for analysis are summarised in Table 1.

Influence of statistical method used on the resulting estimate on normal range. Partitioning reference intervals by use of genetic information. Baadenhuijsen H, Smith CJ. Ichihara K, Boyd J. The document provides the laboratory with guidance to define criteria for selecting a healthy reference population, determine how many subjects are needed, identify outliers, and perform the calculations necessary to generate a valid reference interval.

Reference values are calculated specific to health whereas CDLs indicate sensitivity to disease Sign In or Create an Account.

The concept of reference values. Inherent biological variation and reference values. 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 decision limits and partitioning by genetic effects on RIs. Receive exclusive offers and updates c28-w3 Oxford Academic.